sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 3 ]

52

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer. * If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer. * If BAY43-9006 helps to slow the worsening of non-small cell lung cancer. * If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.

In addition to the key secondary outcome parameters several potential biomarkers were evaluated as exploratory parameters. Issues on safety are addressed in the Adverse Event section. The following acronyms and abbreviations were used in the Adverse Event section and Limitations and Caveats section: * gastrointestinal (GI) * not otherwise specified (NOS) * central nervous system (CNS) * National Cancer Institute Common Terminology Criteria (NCI-CTC) * Medical Dictionary for Regulatory Activities (MedDRA) * System Organ Class (SOC) * interim analysis (IA)

Cancer Carcinoma, Non-Small Cell Lung

NSCLC

null

1

arm 1: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles

[ 0 ]

1

[ 0 ]

intervention 1: BAY43-9006 400 mg bid X 28 day cycles \[Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.

intervention 1: Sorafenib (Nexavar, BAY43-9006)

2

0

NCT00101413

[ 5 ]

177

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals.

GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. Standard treatment for GAD typically involves selective serotonin reuptake inhibitors (SSRIs), drugs that reduce serotonin re-entry into nerve cells. Escitalopram is an SSRI that is well tolerated and highly specific for the serotonin transporter (SERT). The primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly GAD patients. Additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the SERT gene influences these participants' response to treatment. Participants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). Participants will have weekly/biweekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. Blood collection and cognitive testing through various tasks will also occur.

Anxiety Disorders Generalized Anxiety Disorder

Anxiety Elderly Aged Serotonin Reuptake Inhibitors SSRI SERT

null

2

arm 1: Escitalopram arm 2: Placebo

[ 0, 2 ]

1

[ 0 ]

intervention 1: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.

intervention 1: Escitalopram

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00105586

[ 3 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations. The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints. The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).

Carcinoma, Hepatocellular

Cancer Liver Cancer Hepatocellular carcinoma HCC

null

2

arm 1: "Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks) arm 2: "Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Multi kinase inhibitor plus Chemotherapy intervention 2: Chemotherapy plus Placebo

intervention 1: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin intervention 2: Doxorubicin/Placebo

28

0

NCT00108953

[ 3 ]

9

NA

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

false

1FEMALE

true

RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer. PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer.

OBJECTIVES: Primary * Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot flashes, in terms of hot flash frequency, score, and duration and disruption of daily activities caused by hot flashes, in postmenopausal women with non-metastatic breast cancer. * Determine hot flash changes over 4 weeks in patients treated with this drug. Secondary * Determine the toxicity of this drug in these patients. * Determine the effect of Hypericum perforatum (St. John's wort) on serum tamoxifen levels in women receiving tamoxifen therapy. * Determine the effect of Hypericum perforatum (St. John's wort) on general health-related quality of life and mood at 2 and 4 weeks relative to baseline, and during the 2 week post-treatment phase in these patients. * To evaluate changes in average weekly hot flush scores and duration over course of study. OUTLINE: This is a multicenter study. Patients receive oral Hypericum perforatum (St. John's wort) three times daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients complete a daily diary of the frequency, severity, and duration of their hot flashes, and complete quality of life and mood assessments every 2 weeks during study treatment and continuing weekly for 2 weeks after completion of study treatment. Patients receiving tamoxifen will have blood tests to measure serum tamoxifen levels at baseline, 2, 4, and 6 weeks. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Breast Cancer Hot Flashes

recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer breast cancer in situ ductal breast carcinoma in situ hot flashes

null

1

arm 1: Patient given one 300mg St. John's Wort tablet three times per day

[ 0 ]

1

[ 0 ]

intervention 1: St. John's Wort 300mg tablet three times per day

intervention 1: St. John's Wort

19

0

NCT00110136

[ 3 ]

212

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.

null

Sickle Cell Disease Iron Overload Hemolytic Anemia

Sickle Cell Disease Iron Overload from Repeated Blood Transfusions Iron Overload Blood Transfusions

null

2

arm 1: Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. arm 2: Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day. intervention 2: Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.

intervention 1: Deferasirox (ICL670) intervention 2: Deferoxamine (DFO)

59

0

NCT00110617

[ 3 ]

56

RANDOMIZED

PARALLEL

null

2DOUBLE

false

0ALL

false

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

null

Arthritis, Rheumatoid

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: solution, intravenous injection, monthly, 169 days weight based: \<60 kg = 500 mg 60 to 100 kg = 750 mg \>100 kg = 1 g intervention 2: solution, intravenous injection, 0 mg, monthly, 169 days

intervention 1: Abatacept intervention 2: placebo

48

0

NCT00124449

[ 3 ]

90

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will have the option of continuing in an open-label extension study.

Parkinson's Disease is a progressive neurodegenerative disorder characterized by bradykinesia, rigidity, tremor and abnormal posture and gait. Many patients can have mild to moderate symptoms, while others with advanced disease have symptoms which interfere with activities of daily living to a severe degree. Although effective in addressing motor dysfunction, long-term use of anti-Parkinsonian agents has been implicated as a component in the development of psychiatric side effects including psychosis. Treatment of psychosis with typical antipsychotics is not recommended in this patient population, since even low potency typical antipsychotics can cause marked exacerbations of parkinsonism in Parkinson's disease patients. The use of atypical antipsychotics (e.g., clozapine, risperidone and quetiapine) has shown some efficacy in the treatment of psychosis in PD patients. Melperone is classified atypical antipsychotic. European experience with melperone spans more than 30 years, and it encompasses an established antipsychotic efficacy profile in the treatment of confusion, anxiety, unrest (particularly in the elderly) and schizophrenia as well as a favorable safety and tolerability profile. Eligible subjects with Parkinson's disease psychosis will participate in a 1-2 week Screening/Washout Period, a 5 week Titration Phase (one of three doses of melperone or placebo), a 1 week Maintenance Phase and a Taper/Follow-up Period up to 2 weeks. Following the Day 43 assessment, subjects may be given the option of receiving melperone in an open-label extension study.

Parkinson's Disease Psychotic Disorders

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 20 mg/day. Strength of melperone syrup is 5 mg/mL intervention 2: 40 mg/day. Strength of melperone syrup is 5 mg/mL intervention 3: 60 mg/day. Strength of melperone syrup is 5 mg/mL intervention 4: Syrup formulation

intervention 1: Melperone HCl intervention 2: Melperone HCl intervention 3: Melperone HCl intervention 4: Placebo

21

0

NCT00125138

[ 3 ]

210

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals.

Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose of this study is to determine whether modafinil improves abstinence during early recovery from cocaine dependence. This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks. Participants will be randomly assigned to receive a single morning dose of low-dose modafinil (200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition, each week participants will receive manual-guided cognitive behavioral therapy at the Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo will be abruptly discontinued. One week following, an end of medication evaluation will occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after initial randomization. Efforts will be made to continue evaluation of subjects who decide to discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be evaluated.

Cocaine-Related Disorders

cocaine

null

3

arm 1: Low Dose Modafinil 200 mg daily arm 2: High dose modafinil 400 mg daily arm 3: Placebo

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: modafinil 200 mg/day intervention 2: modafinil 400 mg/day intervention 3: placebo 400 mg/day

intervention 1: Low Dose Modafinil intervention 2: High Dose Modafinil intervention 3: Placebo

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00129285

[ 3 ]

16

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.

* The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression. * Starting on the second week, patients will begin treatment with rituximab intravenously once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and possible decadron). During the infusion, the patients' blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects. Blood work will also be performed each week. * On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If the disease has gone away completely, some tests may be repeated again to confirm this. * If the disease has gotten worse after 12 weeks, then the patient will be removed from the study. * If the disease is stable or getting better, the patient will continue with therapy. During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated until the patient has completed 48 weeks (12 months) of treatment as long as the side effects are acceptable and the disease does not progress. * All patients will undergo an off-study evaluation that includes a physical exam, blood work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and the disease does not get worse, they will be evaluated every 12 weeks to determine the status of their disease for up to 2 years.

Waldenstrom's Macroglobulinemia

CC-5103 (lenalidomide) rituximab Waldenstrom's macroglobulinemia

null

1

arm 1: Intended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide) intervention 2: Begins on week 2 of treatment and is given intravenously once a week for 4 weeks

intervention 1: CC-5103 (lenalidomide) intervention 2: Rituximab

2

0

NCT00142168

[ 5 ]

45

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

true

To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

null

Prophylaxis Of Invasive Fungal Infections

Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Voriconazole is given to patients at least 48 hours after chemotherapy

intervention 1: voriconazole

17

Leuven | N/A | Belgium | 4.70093 | 50.87959 Marseille | Cedex 09 | France | 5.38107 | 43.29695 Créteil | N/A | France | 2.46569 | 48.79266 Nantes | N/A | France | -1.55336 | 47.21725 Pessac | N/A | France | -0.6324 | 44.80565 Strasbourg | N/A | France | 7.74553 | 48.58392 Cologne | N/A | Germany | 6.95 | 50.93333 Mainz | N/A | Germany | 8.2791 | 49.98419 Würzburg | N/A | Germany | 9.95121 | 49.79391 Lisbon | Lisbon District | Portugal | -9.1498 | 38.72509 Barcelona | Barcelona | Spain | 2.15899 | 41.38879 Barcelona | Barcelona | Spain | 2.15899 | 41.38879 Madrid | Madrid | Spain | -3.70256 | 40.4165 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Ch-4031 Basel | N/A | Switzerland | N/A | N/A London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT00143312

[ 3 ]

143

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will look at whether study participants recover more quickly and have fewer side effects if they are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as compared to the standard treatment. Participants will be followed for approximately 6 months from the time they are enrolled into the study.

This study is designed to address the need for more effective antifungal therapy for cryptococcal meningitis. This is a prospective, randomized, open-label, multicenter phase II clinical trial of combination therapy for the treatment of acute cryptococcal meningitis in HIV-positive subjects. The primary study objectives will be to assess the safety and tolerability of the study drug regimens; and to determine whether the safety and efficacy of combination therapy supports development of a phase III trial of combination therapy, and if so, to select the most appropriate dose of fluconazole plus amphotericin B based on safety and efficacy to be evaluated in a subsequent phase III trial. Secondary study objectives include: comparing the efficacy of the study drug treatments at 2, 6, and 10 weeks (Days 14, 42, and 70); comparing the findings on detailed neurological examination between study arms at baseline and 2, 6, 10, and 24 weeks (6 months); assessing the proportion of subjects in each study arm that are alive at 6 months after initiation of study therapy; describing the effects of baseline clinical, neurological, and mycological characteristics on mycological failure at 2 and 10 weeks; measuring time to cerebrospinal fluid (CSF) culture negatively for each study arm; assessing the length of hospitalization in the treatment groups as a surrogate of cost efficacy; assessing the incidence of immune reconstitution inflammatory syndrome among all subjects receiving highly active antiretroviral therapy (HAART); and examining antifungal susceptibility of all cryptococcal isolates. Study participants will include 150 subjects ages 13 and older. Subjects will be randomly assigned to 1 of 3 treatment arms including 1 standard therapy and 2 investigational arms. The standard treatment arm will include amphotericin B 0.7 mg/kg (IV) for 14 days followed by 8 weeks (56 days) of fluconazole at 400 mg/day orally. The 2 investigational arms will include daily amphotericin B 0.7 mg/kg (IV) and the randomized dose of fluconazole 400 mg/day or 800 mg/day for the first 14 day, then the randomized dose of fluconazole at 400 mg/day or 800 mg/day respectively for an additional 8 weeks (56 days). At the completion of study therapy, all subjects will receive chronic suppressive therapy with oral fluconazole at a dose of at least 200 mg/day. The safety endpoints are considered to be the primary endpoints for this study. The safety assessment for each treatment arm will end at study day 100 for each subject. The key safety endpoint will be the incidence of adverse experiences of grade 3-5 (total and attributed to the treatment regimens). The primary safety endpoint will examine the incidence of grade 3-5 adverse experiences that are definitely or probably related to study drugs, while secondary analysis will include grade 3-5 adverse experiences that are, definitely probably or possibly related to study drugs. Another secondary safety endpoint will be the number of dose-limiting toxicities attributed to the treatment regimens. Key efficacy endpoint (treatment success) will be a composite of the following 3 mycologic and clinical measures after 14, 42, and 70 days of therapy: CSF culture conversion; neurologically stable or improved; and alive. Other secondary efficacy endpoints that will be evaluated descriptively are: CSF culture conversion at multiple time points; all-cause mortality; length of hospitalization; and incidence of immune reconstitution inflammatory syndrome.

Cryptococcal Meningitis

Bacterial infections, HIV infection, cryptococcal meningitis

null

3

arm 1: Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed. arm 2: Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks. arm 3: Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.

[ 1, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Amphotericin B 0.7 mg/kg IV for the first 14 days of treatment. This period may be extended up to an additional 7 days. intervention 2: Fluconazole 400 or 800 mg daily. Among subjects whose baseline weight is less than 40 kg, randomized fluconazole doses will be 200 mg/kg daily or 400 mg/kg daily.

intervention 1: Amphotericin B intervention 2: Fluconazole

15

0

NCT00145249

[ 3 ]

50

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.

* Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle. * Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours. * On day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered. * On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered. * Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects. * Scans (CT, MRI or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.

Prostate Cancer

Advanced Prostate Cancer Prostate Cancer Trabectedin ET 743 Yondelis

null

1

arm 1: ET-743

[ 0 ]

1

[ 0 ]

intervention 1: ET-743 administered IV by 24-hr infusion every 3 weeks

intervention 1: ET 743

2

0

NCT00147212

[ 4 ]

506

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years. The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

null

Transfusional Iron Overload in β-thalassemia

β-thalassemia iron overload deferasirox

null

1

arm 1: All participants received Deferasirox (ICL670) orally once a day. Dosage based on body weight.

[ 0 ]

1

[ 0 ]

intervention 1: Tablets taken orally once a day.

intervention 1: Deferasirox

49

Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Stanford | California | United States | -122.16608 | 37.42411 Chicago | Illinois | United States | -87.65005 | 41.85003 Boston | Massachusetts | United States | -71.05977 | 42.35843 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Córdoba | N/A | Argentina | -64.18853 | -31.40648 Brussels | N/A | Belgium | 4.34878 | 50.85045 Laken | N/A | Belgium | 4.34844 | 50.87585 Liège | N/A | Belgium | 5.56749 | 50.63373 Mons | N/A | Belgium | 3.95229 | 50.45413 Campinas | N/A | Brazil | -47.06083 | -22.90556 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Montreal | N/A | Canada | -73.58781 | 45.50884 Toronto | N/A | Canada | -79.39864 | 43.70643 Créteil | N/A | France | 2.46569 | 48.79266 Marseille | N/A | France | 5.38107 | 43.29695 Paris | N/A | France | 2.3488 | 48.85341 Pierre-Bénite | N/A | France | 4.82424 | 45.70359 Berlin | N/A | Germany | 13.41053 | 52.52437 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Hamburg | N/A | Germany | 9.99302 | 53.55073 Ulm | N/A | Germany | 9.99155 | 48.39841 Athens | N/A | Greece | 23.72784 | 37.98376 Ioannina | N/A | Greece | 20.85189 | 39.66486 Pátrai | N/A | Greece | 21.73444 | 38.24444 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Brindisi | N/A | Italy | 17.93607 | 40.63215 Cagliari | N/A | Italy | 9.11917 | 39.23054 Catania | N/A | Italy | 15.07041 | 37.49223 Ferrara | N/A | Italy | 11.62057 | 44.83804 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 9.18951 | 45.46427 Monza | N/A | Italy | 9.27246 | 45.58005 Naples | N/A | Italy | 14.26811 | 40.85216 Palermo | N/A | Italy | 13.3636 | 38.1166 Pavia | N/A | Italy | 9.15917 | 45.19205 Roma | N/A | Italy | 11.10642 | 44.99364 Sassari | N/A | Italy | 8.55552 | 40.72586 Syracuse | N/A | Italy | 15.28664 | 37.07542 Turin | N/A | Italy | 7.68682 | 45.07049 Tunis | N/A | Tunisia | 10.16579 | 36.81897 Adana | N/A | Turkey (Türkiye) | 35.32531 | 36.98615 Isparta | N/A | Turkey (Türkiye) | 30.55222 | 37.76444 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00171210

[ 5 ]

14

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

0ALL

true

In this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for CDAD. We expect to enroll approximately 40 patients over a period of two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who are unresponsive to standard antimicrobial therapy for CDAD. During the course of this study we expect that IVIG group compared with placebo group will have fewer number of stools per day (\< 3 per day). Secondary endpoints will include normal WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and decrease in length of hospital stay. Subjects will sign a written informed consent prior to any study procedures. Patients will be monitored closely during the infusion of the study medication and will continue to be monitored on a daily basis up to the time of discharge. Data collection will include vital signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.

See "Brief Summary" for details

Clostridium Difficile-associated Diarrhea (CDAD)

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: IVIG to be given IV to patients with C-Diff . intervention 2: Placebo to be given IV to patients with C-Diff

intervention 1: intravenous immunoglobulin G (IVIG) intervention 2: Placebo

4

0

NCT00177970

[ 3 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

null

The purpose of this study is to determine if treatment using a medication (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any active medication, when combined with testosterone replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole, the medication that is currently under study, does not, at this time, have FDA approval for use for this indication.

This is a three-month study where baseline information is collected at the first visit and then each patient is started on treatment with testosterone supplementation and either anastrozole or placebo. Lab tests, seizure frequency, sexual function and mood will be monitored on a monthly basis.

Seizure Disorder Hypogonadism Erectile Dysfunction

Seizure Epilepsy Testosterone Hormone Sexual Dysfunction Hypogonadism Men

null

2

arm 1: Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes an oral tablet of anastrozole 1 mg daily for the duration of the study. This group is referred to as the depotestosterone plus anastrozole (T-A) group. arm 2: Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo oral tablet daily for the duration of the study. This group is referred to as the depotestosterone plus placebo (T-P) group.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Anastrozole 1mg intervention 2: Placebo Oral Tablet

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00179517

[ 3 ]

43

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28-day cycle. Treatment will continue for up to 52 weeks or until disease progression; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progression free survival following discontinuation from the treatment phase

null

Non-Hodgkins Lymphoma

NHL CC5013 Non-Hodgkins Lymphoma revlimid cc-5013 celgene

null

1

arm 1: Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Lenalidomide

15

0

NCT00179673

[ 5 ]

51

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.

Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania,\& mixed episodes) in patients treated for acute mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance treatment was more robust in bipolar depression. The study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of safety and tolerability.

Bipolar Disorder Mania

bipolar disorder lamotrigine children mania

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children \<12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.

intervention 1: lamotrigine

1

Cambridge | Massachusetts | United States | -71.10561 | 42.3751

0

NCT00181844

[ 5 ]

23

NON_RANDOMIZED

PARALLEL

null

0NONE

true

0ALL

true

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin.

The drug, which is used in the treatment of Type II diabetes, has a narrow therapeutic range. Its net renal clearance by secretion (i.e., renal clearance minus filtration clearance) ranges from approximately 100 ml/min to 800ml/min in normal, healthy subjects. Although many factors may contribute to inter-individual variation in renal secretory clearance, initial estimates of heritability (greater than 0.6) suggest that genetic factors play an important role in the renal secretion of metformin. Available evidence supports the idea that hOCT2 is the primary transporter involved in the first-step of renal secretion of metformin, i.e., uptake from the blood to the tubule cell across the basolateral membrane. In particular, (a) hOCT2 is the primary organic cation transporter on the basolateral membrane of the human kidney; and (b) metformin interacts with and is translocated by hOCT2 in heterologous expression systems. In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% \[6\] that have altered function in studies in heterologous expression systems. In addition, we identified a common haplotype of hOCT2 and one haplotype that contain the non-synonymous cSNP, A270S. We will determine whether variability in the renal secretory clearance of the model organic cation, metformin, in healthy individuals is associated with genetic variation in hOCT2. In particular, we will determine whether the renal clearance of metformin differs in individuals who are homozygous for the common haplotype of OCT2 (OCT2\*1) and those who are heterozygous for the less common haplotype OCT2\*3D, which we have identified in a comprehensive screen of ethnically identified DNA samples. We will also determine whether individuals who are heterozygous for the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of metformin.

Other Conditions That May Be A Focus of Clinical Attention

Healthy Control

null

2

arm 1: Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin. arm 2: Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Subjects will be given a single oral dose of 850 mg of metformin

intervention 1: Metformin

1

San Francisco | California | United States | -122.41942 | 37.77493

0

NCT00187720

[ 3 ]

60

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.

As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Leukemia, Lymphocytic, Chronic, B-Cell

null

1

arm 1: Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.

[ 0 ]

1

[ 0 ]

intervention 1: Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days

intervention 1: Alemtuzumab plus Fludarabine

27

0

NCT00206726

[ 3 ]

68

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

true

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis, however, this agent has a roughly 30% incidence of gastrointestinal symptoms and up to 50% of patients may take the drug improperly, compromising absorption and potentially efficacy. Zoledronate is a heterocyclic imidazole third generation bisphosphonate, which is administered intravenously (IV) and has little toxicity. Zoledronate is more potent than alendronate, and because of its route of administration it does not have the problems of poor oral bioavailability and non-compliance.

Breast Cancer

bone mineral density postmenopausal women

null

2

arm 1: Observation only for 12 months arm 2: Zoledronate

[ 4, 1 ]

1

[ 0 ]

intervention 1: 4 mg IV over 15 minutes administered once every 12 weeks times 4

intervention 1: Zoledronate

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00213980

[ 4 ]

539

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Seizures

Partial Seizures Complex Partial Seizures Epilepsy Potassium Channels Anticonvulsant

null

3

arm 1: None arm 2: None arm 3: None

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase. intervention 2: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase. intervention 3: Oral tablet.

intervention 1: Retigabine intervention 2: Retigabine intervention 3: Placebo

70

Bethesda | Maryland | United States | -77.10026 | 38.98067 Dallas | Texas | United States | -96.80667 | 32.78306 Camperdown | New South Wales | Australia | 151.17642 | -33.88965 Maroochydore | Queensland | Australia | 153.09953 | -26.66008 Clayton | Victoria | Australia | 145.11667 | -37.91667 Parkville | Victoria | Australia | 144.95 | -37.78333 West Heidelberg | Victoria | Australia | N/A | N/A Antwerp | N/A | Belgium | 4.40026 | 51.22047 Bruges | N/A | Belgium | 3.22424 | 51.20892 Leuven | N/A | Belgium | 4.70093 | 50.87959 Ottignies | N/A | Belgium | 4.56679 | 50.66535 Lyon | Lyonnais | France | 4.84671 | 45.74846 Rennes | N/A | France | -1.67429 | 48.11198 Strasbourg | N/A | France | 7.74553 | 48.58392 Tain-l'Hermitage | N/A | France | 4.8559 | 45.06672 Bonn | N/A | Germany | 7.09549 | 50.73438 Erlangen | N/A | Germany | 11.00783 | 49.59099 Göttingen | N/A | Germany | 9.93228 | 51.53443 Mainz | N/A | Germany | 8.2791 | 49.98419 Marburg | N/A | Germany | 8.77069 | 50.80904 Munich | N/A | Germany | 11.57549 | 48.13743 Ulm | N/A | Germany | 9.99155 | 48.39841 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Ashkelon | N/A | Israel | 34.57149 | 31.66926 Beer Yaakov | N/A | Israel | N/A | N/A Haifa | N/A | Israel | 34.99928 | 32.81303 Holon | N/A | Israel | 34.77918 | 32.01034 Nahariya | N/A | Israel | 35.09814 | 33.00892 Ramat Gan | N/A | Israel | 34.81065 | 32.08227 Rehovot | N/A | Israel | 34.81199 | 31.89421 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Padlewskiego 4 | Plock | Poland | N/A | N/A Bialystok | N/A | Poland | 23.16433 | 53.13333 Gdansk | N/A | Poland | 18.64912 | 54.35227 Katowice | N/A | Poland | 19.02754 | 50.25841 Lublin | N/A | Poland | 22.56667 | 51.25 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Kazan' | N/A | Russia | 49.12214 | 55.78874 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Port Elizabeth | East Cape | South Africa | 25.61494 | -33.96109 Bloemfontein | Gauteng | South Africa | N/A | N/A Pretoria | Gauteng | South Africa | 28.18783 | -25.74486 Sunninghill | Gauteng | South Africa | 28.06552 | -26.0355 Johannesburg | Gauten | South Africa | 28.04363 | -26.20227 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Belville | West Cape | South Africa | 18.63486 | -33.89404 Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Barcelona | N/A | Spain | 2.15899 | 41.38879 Bilbao | N/A | Spain | -2.92528 | 43.26271 Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283 Granada | N/A | Spain | -3.60667 | 37.18817 Madrid | N/A | Spain | -3.70256 | 40.4165 Zaragoza | N/A | Spain | -0.87734 | 41.65606 Dnipro | N/A | Ukraine | 35.04066 | 48.46664 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Middlesbrough | Mersyd | United Kingdom | -1.23483 | 54.57623 Blackpool | N/A | United Kingdom | -3.05 | 53.81667 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00235755

[ 4 ]

435

NON_RANDOMIZED

PARALLEL

2DIAGNOSTIC

0NONE

false

0ALL

false

This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician. Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Computed Tomography Diagnostic Imaging

Ultravist 370 CECT CT Scan

null

2

arm 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously arm 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously intervention 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously

intervention 1: Iopromide 370 mg I/mL intervention 2: Iopromide 300 mg I/mL

23

0

NCT00244140

[ 4 ]

1,294

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Postmenopausal Osteoporosis

randomized controlled trial, osteoporosis, risedronate

null

2

arm 1: 5 mg risedronate, once daily for 2 years arm 2: 150 mg risedronate taken once a month for 2 years

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: tablet, 5 mg risedronate, once a day for 2 years intervention 2: oral, 150 mg risedronate, once a month for 2 years

intervention 1: risedronate intervention 2: risedronate

49

Lakewood | Colorado | United States | -105.08137 | 39.70471 Gainesville | Georgia | United States | -83.82407 | 34.29788 Bethesda | Maryland | United States | -77.10026 | 38.98067 Omaha | Nebraska | United States | -95.94043 | 41.25626 West Haverstraw | New York | United States | -73.98542 | 41.20954 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Portland | Oregon | United States | -122.67621 | 45.52345 Buenos Aires | Buenos Aires | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Geelong | N/A | Australia | 144.36069 | -38.14711 Heidelberg, Victoria | N/A | Australia | 145.06667 | -37.75 Saint Leonards | N/A | Australia | 144.71803 | -38.17051 Brussels | N/A | Belgium | 4.34878 | 50.85045 Ghent | N/A | Belgium | 3.71667 | 51.05 Leuven | N/A | Belgium | 4.70093 | 50.87959 Liège | N/A | Belgium | 5.56749 | 50.63373 Mont Godinne | N/A | Belgium | N/A | N/A Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Calgary | N/A | Canada | -114.08529 | 51.05011 Montreal | N/A | Canada | -73.58781 | 45.50884 Sainte-Foy | N/A | Canada | -71.29217 | 46.78139 Saskatoon | N/A | Canada | -106.66892 | 52.13238 Pärnu | N/A | Estonia | 24.49711 | 58.38588 Tartu | N/A | Estonia | 26.72509 | 58.38062 Helsinki | N/A | Finland | 24.93545 | 60.16952 Kuopio | N/A | Finland | 27.67703 | 62.89238 Oulu | N/A | Finland | 25.46816 | 65.01236 Turku | N/A | Finland | 22.26869 | 60.45148 Amiens | N/A | France | 2.3 | 49.9 Lyon | N/A | France | 4.84671 | 45.74846 Orléans | N/A | France | 1.90389 | 47.90289 Paris | N/A | France | 2.3488 | 48.85341 Toulouse | N/A | France | 1.44367 | 43.60426 Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115 Balatonfüred | N/A | Hungary | 17.87187 | 46.96188 Budapest | N/A | Hungary | 19.04045 | 47.49835 Győr | N/A | Hungary | 17.63512 | 47.68333 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Nagykanizs | N/A | Hungary | N/A | N/A Beirut | N/A | Lebanon | 35.50157 | 33.89332 Oslo | N/A | Norway | 10.74609 | 59.91273 Paradis | N/A | Norway | 5.34607 | 60.33664 Trondheim | N/A | Norway | 10.39506 | 63.43049 Bialystok | N/A | Poland | 23.16433 | 53.13333 Warsaw | N/A | Poland | 21.01178 | 52.22977 Barcelona | N/A | Spain | 2.15899 | 41.38879 Granada | N/A | Spain | -3.60667 | 37.18817 Madrid | N/A | Spain | -3.70256 | 40.4165

0

NCT00247273

[ 4 ]

4,717

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy. The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER). This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.

null

Type 2 Diabetes

Diabetes mellitus type 2

null

2

arm 1: candesartan cilexetil 32 mg once daily arm 2: control

[ 0, 4 ]

1

[ 0 ]

intervention 1: 32 mg oral tablet

intervention 1: candesartan

0

null

0

NCT00252694

[ 5 ]

275

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions to immunotherapy in patients with persistent allergic asthma.

null

Allergic Asthma

Allergic Asthma, IgE, immunotherapy, omalizumab

null

2

arm 1: The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram. arm 2: The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.

[ 2, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Doses of placebo were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE. intervention 2: Doses of omalizumab were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE. intervention 3: Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or "maintenance" solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours. intervention 4: Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or "maintenance" solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours.

intervention 1: Placebo intervention 2: Omalizumab intervention 3: Immunotherapy intervention 4: Immunotherapy

1

East Hanover | New Jersey | United States | -74.36487 | 40.8201

0

NCT00267202

[ 3 ]

4

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The goal of this clinical research study is to learn how the drug ZD6474 affects the amount of tumor cell death in the body and the amount of blood that can be supplied to the tumor. The safety of ZD6474 alone and when given with chemotherapy will be studied. In addition, the side effects and response to this treatment will also be studied.

ZD6474 is a new investigational drug that is thought to block the formation of new blood vessels. The growth of new blood vessels is called angiogenesis. Angiogenesis is thought to be essential for the growth of tumors beyond a small size. It is hoped that ZD6474 will limit new blood vessel growth in the tumor and "starve" the tumor by limiting blood flow to it. The second part of this study also includes paclitaxel (Taxol) and carboplatin (Paraplatin). Both paclitaxel and carboplatin are standard chemotherapy drugs that are approved by the FDA for use in the treatment of lung cancer. Before beginning treatment on this study, you will have a biopsy of your tumor. The tissue taken during this biopsy will be compared with the tissue taken after you receive ZD6474. The tumor samples will be compared to see what effect ZD6474 has had on tumor cell death. During the biopsy procedure, you will receive either a local or general anesthetic depending on the location of your tumor and a small piece of tumor will be removed with a large needle. Before treatment starts, you will have a complete physical exam by a physician. You will have routine blood (about 4 teaspoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. You will have a chest x-ray and a CT or MRI scan, a functional MRI, a bone scan if your doctor thinks it is necessary, and a brain scan. You will also have an ECG (test to measure the electrical activity of the heart) and a ECHO scan to make sure your heart is healthy enough to receive this treatment. Treatment on this study will be given in 3-week cycles. During the first three cycles (i.e., the first 9 weeks) you will take a ZD6474 tablet by mouth each morning on an empty stomach. While on this study you will receive a physical exam every week. You will also receive weekly blood tests (about 4 teaspoons) for the first 4 weeks of treatment. After that you will receive blood tests (about 4 teaspoons) before every 3-week cycle. After 2 weeks of treatment you will have another biopsy of your tumor, and another functional MRI. After every 9 weeks of treatment and every 2 cycles thereafter you will have a repeat CT or MRI to evaluate your tumor. If your disease has responded to ZD6474 or stayed the same, you will go on to the second part of this study. If your disease has gotten worse or intolerable side effects occur, you will be taken off this study and your doctor will discuss treatment options with you. If you continue on to the second part of this study, you will be randomly assigned (as in the toss of a coin) to receive either: a) daily ZD6474 alone, or b) paclitaxel and carboplatin every 3 weeks along with daily ZD6474. You have an equal chance of being assigned to either group. If you receive paclitaxel, you will receive it as a 3-hour infusion into a vein on the first day of each treatment cycle. If you receive carboplatin, you will receive it by vein immediately following the paclitaxel infusion. The carboplatin infusion will take between 15 and 30 minutes. Treatment with either daily ZD6474 or ZD6474 plus paclitaxel and carboplatin will continue until your diseases worsens or until severe side effects occur. This is an investigational study. ZD6474 is an investigational drug that has been approved by the FDA for research use only. A total of up to 120 patients will take part in this study. All will be enrolled at M. D. Anderson.

Lung Cancer

Non-Small Cell Lung Cancer Lung Cancer Carboplatin Paclitaxel ZD6474 NSCLC

null

3

arm 1: First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 every 3 weeks. arm 2: Second part of study where participants randomized to receive 300 mg of ZD6474 daily (group A) arm 3: Second part of study where participants randomized to receive 100 mg of ZD6474 daily plus carboplatin AUC 6.0 IV over 15-30 minutes and paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 every 3 weeks (group B).

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: ZD6474 alone: Cycles 1-3 = 300 mg PO Daily x 3 Weeks; ZD6474+Carboplatin+Paclitaxel = 300 mg oral (PO) Daily or 100 mg PO Daily plus Carboplatin and Paclitaxel Every 3 Weeks. intervention 2: 6 AUC IV Over 15-30 Minutes, Immediately After Paclitaxel intervention 3: 200 mg/m\^2 IV Over 3 Hours On Day 1

intervention 1: ZD6474 intervention 2: Carboplatin intervention 3: Paclitaxel

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00290537

[ 4 ]

130

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe. To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

null

Epilepsy

NEWLY DIAGNOSED EPILEPSY LEVETIRACETAM KEPPRA N01175 (NCT00175903)

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study

intervention 1: Levetiracetam

35

Bruges | N/A | Belgium | 3.22424 | 51.20892 Edegem | N/A | Belgium | 4.44504 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05 Haine-Saint-Paul | N/A | Belgium | 4.1885 | 50.45544 Jette | N/A | Belgium | 4.33419 | 50.87309 Kortrijk | N/A | Belgium | 3.26487 | 50.82803 Leuven | N/A | Belgium | 4.70093 | 50.87959 Ostend | N/A | Belgium | 2.927 | 51.21551 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Hus (helsinki) | N/A | Finland | N/A | N/A Kuopio | N/A | Finland | 27.67703 | 62.89238 Tampere | N/A | Finland | 23.78712 | 61.49911 Blaye | N/A | France | -0.66225 | 45.12764 Bordeaux | N/A | France | -0.5805 | 44.84044 Brest | N/A | France | -4.48628 | 48.39029 Carcassonne | N/A | France | 2.34863 | 43.21649 Cherbourg | N/A | France | -1.61636 | 49.63984 Lille | N/A | France | 3.05858 | 50.63297 Lyon | N/A | France | 4.84671 | 45.74846 Nancy | N/A | France | 6.18496 | 48.68439 Rennes | N/A | France | -1.67429 | 48.11198 Saint-Brieuc | N/A | France | -2.76838 | 48.51513 Saint-Quentin | N/A | France | 3.28757 | 49.84889 Toulouse | N/A | France | 1.44367 | 43.60426 Valenciennes | N/A | France | 3.52506 | 50.35909 Częstochowa | N/A | Poland | 19.12409 | 50.79646 Krakow | N/A | Poland | 19.93658 | 50.06143 Olsztyn | N/A | Poland | 20.49416 | 53.77995 Poznan | N/A | Poland | 16.92993 | 52.40692 Warsaw | N/A | Poland | 21.01178 | 52.22977 Biel | N/A | Switzerland | 8.21773 | 46.45587 Lausanne | N/A | Switzerland | 6.63282 | 46.516 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 Zurich | N/A | Switzerland | 8.55 | 47.36667

0

NCT00291655

[ 4 ]

696

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\] .

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\].

Hepatitis C, Chronic

Hepatitis C, Chronic Genotype 2 and Genotype 3

null

3

arm 1: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks arm 2: PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks arm 3: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks

[ 1, 0, 0 ]

5

[ 2, 2, 2, 0, 0 ]

intervention 1: 1.5 mcg/kg QW SC for 24 weeks intervention 2: 1.0 mcg/kg QW SC for 24 weeks intervention 3: 1.5 mcg/kg QW SC for 16 weeks intervention 4: 800-1200 mg daily for 24 weeks intervention 5: 800-1200 mg daily for 16 weeks

intervention 1: peginterferon alfa-2b (SCH 54031) intervention 2: peginterferon alfa-2b (SCH 54031) intervention 3: peginterferon alfa-2b (SCH 54031) intervention 4: ribavirin (SCH 18908) intervention 5: ribavirin (SCH 18908)

0

null

0

NCT00302081

[ 5 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. Preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER can improve cognitive impairment in patients. The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

Schizophrenia Schizoaffective Disorder

schizophrenia, cognition, mood stabilizer

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: divalproex sodium extended-release (ER) 1000 mg intervention 2: placebo identical in appearance to active comparator

intervention 1: Divalproex Sodium Extended-Release Tablets intervention 2: placebo

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00306475

[ 5 ]

694

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

null

Essential Hypertension

Olmesartan medoxomil Hypertension

null

1

arm 1: Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks

[ 0 ]

1

[ 0 ]

intervention 1: Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.

intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

79

Fulpmes | N/A | Austria | 11.34922 | 47.15202 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Kundl | N/A | Austria | 11.98333 | 47.46667 Salzburg | N/A | Austria | 13.04399 | 47.79941 Salzburg-Aigen | N/A | Austria | N/A | N/A Brussels | N/A | Belgium | 4.34878 | 50.85045 Mechelen | N/A | Belgium | 4.47762 | 51.02574 Seraing | N/A | Belgium | 5.50115 | 50.58362 Temse | N/A | Belgium | 4.21372 | 51.12794 Ancerville | N/A | France | 5.02091 | 48.63574 Bourges | N/A | France | 2.4 | 47.08333 Derval | N/A | France | -1.67176 | 47.66772 Grenoble | N/A | France | 5.71479 | 45.17869 Lille | N/A | France | 3.05858 | 50.63297 Montrevel-en-Bresse | N/A | France | 5.12269 | 46.33527 Pouilly-en-Auxois | N/A | France | 4.55583 | 47.26238 Poussan | N/A | France | 3.67083 | 43.48944 Saint-Aubin-des-Châteaux | N/A | France | -1.48654 | 47.72024 Saint-Étienne-de-Montluc | N/A | France | -1.78013 | 47.27622 Saint-Priest | N/A | France | 4.94385 | 45.69651 Sorcy-Saint-Martin | N/A | France | 5.63399 | 48.71367 Strasbourg | N/A | France | 7.74553 | 48.58392 Yerres | N/A | France | 2.49338 | 48.71785 Annweiler am Trifels | N/A | Germany | 7.97527 | 49.20613 Balve | N/A | Germany | 7.86424 | 51.3315 Bammental | N/A | Germany | 8.77944 | 49.35611 Bielefeld | N/A | Germany | 8.53333 | 52.03333 Bonn | N/A | Germany | 7.09549 | 50.73438 Goch | N/A | Germany | 6.15895 | 51.67873 Haag | N/A | Germany | 12.07614 | 50.30379 Hamburg | N/A | Germany | 9.99302 | 53.55073 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Heidelberg (Neuenheim) | N/A | Germany | 8.69079 | 49.40768 Mühldorf / Inn | N/A | Germany | N/A | N/A Schwenningen | N/A | Germany | 9.0 | 48.1 VS-Villingen | N/A | Germany | N/A | N/A Weyhe | N/A | Germany | 8.66667 | 52.96667 Albano Laziale (RM) | N/A | Italy | 12.659 | 41.72748 Ascoli Piceno | N/A | Italy | 13.57395 | 42.85351 Barcellona Pozzo Di Gotto (ME) | N/A | Italy | 15.21469 | 38.14772 Bari | N/A | Italy | 16.86982 | 41.12066 Caserta | N/A | Italy | 14.33231 | 41.07262 Catania | N/A | Italy | 15.07041 | 37.49223 Chieti Scalo | N/A | Italy | N/A | N/A Matera | N/A | Italy | 16.60463 | 40.66599 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Palermo | N/A | Italy | 13.3636 | 38.1166 Portogruaro (VE) | N/A | Italy | 12.84052 | 45.78071 Udine | N/A | Italy | 13.23715 | 46.0693 's-Hertogenbosch | N/A | Netherlands | 5.30417 | 51.69917 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Elvas | N/A | Netherlands | N/A | N/A Hilversum | N/A | Netherlands | 5.17639 | 52.22333 Lieshout | N/A | Netherlands | 5.59479 | 51.52036 Waalwijk | N/A | Netherlands | 5.07083 | 51.6825 Almada Almada | N/A | Portugal | N/A | N/A Amadora Amadora | N/A | Portugal | N/A | N/A Lisboa Lisboa | N/A | Portugal | N/A | N/A Affoltern am Albis | N/A | Switzerland | 8.45128 | 47.27743 Bellinzona | N/A | Switzerland | 9.01703 | 46.19278 Gland | N/A | Switzerland | 6.2701 | 46.42082 Petit Lancy | N/A | Switzerland | 6.11359 | 46.19647 Zurich | N/A | Switzerland | 8.55 | 47.36667 Atherstone | N/A | United Kingdom | -1.54693 | 52.57536 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Blackpool | N/A | United Kingdom | -3.05 | 53.81667 Chippenham | N/A | United Kingdom | -2.12472 | 51.46 Coventry | N/A | United Kingdom | -1.51217 | 52.40656 Crawley | N/A | United Kingdom | -0.18312 | 51.11303 Exeter | N/A | United Kingdom | -3.52751 | 50.7236 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Trowbridge | N/A | United Kingdom | -2.20861 | 51.31889

0

NCT00311155

[ 5 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

0ALL

false

Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.

A placebo-controlled, double-blind, crossover trial will be conducted providing study subjects either hydrocodone/acetaminophen 30mg/975mg, sustained release morphine 45mg or placebo on separate GCRC visits. A long acting comparator (slow-release morphine sulfate 45 mg) will be chosen because of its putative equianalgesic effects to the dose of hydrocodone (30 mg) selected. Subjects will participate in the three sessions at the UC Davis/Mather Medical Center General Clinical Research Center (GCRC) at intervals of 7-10 days. Sessions will be approximately 360 min in duration. Subjects will receive either hydrocodone/acetaminophen or sustained release morphine around-the-clock for 7-10 days prior to the experimental session. At each experimental session, an assessment of abuse liability will be completed before the intake of medications, as well as at 0, 60, 120, 180, 240 minutes after the ingestion of the study medication.

Chronic Pain

Chronic Pain Opioids

null

3

arm 1: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocodone-acetaminophen (30/925 mg). arm 2: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On the day of the study session, patients received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP;Qualitest Pharmaceuticals Inc, Huntsville, AL). arm 3: Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.

[ 1, 1, 2 ]

4

[ 5, 0, 0, 0 ]

intervention 1: The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects. intervention 2: None intervention 3: None intervention 4: None

intervention 1: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity intervention 2: ER Morphine intervention 3: hydrocodone plus acetaminophen intervention 4: placebo

0

null

0

NCT00314340

[ 5 ]

220

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de sclérose en plaques. The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis RRMS

null

3

arm 1: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject arm 2: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light arm 3: Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 250ug administrated with Betaject intervention 2: 44ug administered with Rebiject II intervention 3: 250ug administrated with Betaject light

intervention 1: Betaferon/Betaseron intervention 2: Rebif intervention 3: Betaferon/Betaseron

59

Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Alkirch | N/A | France | N/A | N/A Annecy | N/A | France | 6.12565 | 45.90878 Aurillac | N/A | France | 2.43983 | 44.92539 Belfort | N/A | France | 6.85385 | 47.64218 Blaye | N/A | France | -0.66225 | 45.12764 Bordeaux | N/A | France | -0.5805 | 44.84044 Boulogne-sur-Mer | N/A | France | 1.61373 | 50.72485 Brest | N/A | France | -4.48628 | 48.39029 Brive-la-Gaillarde | N/A | France | 1.53326 | 45.1589 Carcassonne | N/A | France | 2.34863 | 43.21649 Castelnau-le-Lez | N/A | France | 3.90137 | 43.63605 ChamaliÃ¿res | N/A | France | N/A | N/A Champigny-sur-Marne | N/A | France | 2.49366 | 48.81642 Colmar | N/A | France | 7.35584 | 48.08078 Corbeil Essones Cedex | N/A | France | N/A | N/A CrÃ©teil | N/A | France | N/A | N/A Dijon | N/A | France | 5.01667 | 47.31667 Dreux | N/A | France | 1.36566 | 48.73649 Dunkirk | N/A | France | 2.37681 | 51.0344 Elbeuf | N/A | France | 1.00288 | 49.28669 Évreux | N/A | France | 1.15082 | 49.02414 Évry | N/A | France | 2.44049 | 48.6328 La Seyne-sur-Mer | N/A | France | 5.87816 | 43.10322 Le Mans | N/A | France | 0.20251 | 48.0021 Le Mans | N/A | France | 0.20251 | 48.0021 Libourne | N/A | France | -0.24186 | 44.91449 Lille | N/A | France | 3.05858 | 50.63297 Lomme | N/A | France | 2.98715 | 50.64358 Lyon | N/A | France | 4.84671 | 45.74846 Marseille | N/A | France | 5.38107 | 43.29695 Montpellier | N/A | France | 3.87635 | 43.61093 Nancy | N/A | France | 6.18496 | 48.68439 Nancy | N/A | France | 6.18496 | 48.68439 Nantes | N/A | France | -1.55336 | 47.21725 Nice | N/A | France | 7.26608 | 43.70313 Nîmes | N/A | France | 4.35788 | 43.83665 Paris | N/A | France | 2.3488 | 48.85341 Pau | N/A | France | -0.35583 | 43.31117 Perpignan | N/A | France | 2.89541 | 42.69764 Poissy | N/A | France | 2.04952 | 48.92902 Quimper | N/A | France | -4.09795 | 47.99597 Quimper | N/A | France | -4.09795 | 47.99597 Reims | N/A | France | 4.02853 | 49.26526 Rennes | N/A | France | -1.67429 | 48.11198 Rouen | N/A | France | 1.09932 | 49.44313 Rueil-Malmaison | N/A | France | 2.18967 | 48.8765 Saint LÃ¿ | N/A | France | N/A | N/A Saint-Etienne | N/A | France | 4.39 | 45.43389 Saint-Herblain | N/A | France | -1.651 | 47.21154 Saint-Omer | N/A | France | 2.26091 | 50.74834 Saint-Quentin | N/A | France | 3.28757 | 49.84889 Strasbourg | N/A | France | 7.74553 | 48.58392 Toulouse | N/A | France | 1.44367 | 43.60426 Tourcoing | N/A | France | 3.16117 | 50.72391 Trélazé | N/A | France | -0.46652 | 47.44629 Vendôme | N/A | France | 1.06556 | 47.79292 Vesoul | N/A | France | 6.14251 | 47.62604 Vichy | N/A | France | 3.42577 | 46.12709

0

NCT00317941

[ 4 ]

55

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

null

Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency

Immunoglobulin Intravenous Agammaglobulinemia Hypogammaglobulinemia Common variable immunodeficiency Immunoglobulin G Children

null

1

arm 1: See Intervention Description

[ 0 ]

1

[ 0 ]

intervention 1: Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

intervention 1: Immunoglobulins Intravenous (Human)

10

0

NCT00322556

[ 4 ]

531

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

null

Age Related Macular Degeneration Choroidal Neovascularization

AMD, ranibizumab

null

1

arm 1: Ranibizumab-naïve (Non-ANCHOR) patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on re-treatment criteria described in the protocol. For patients who had participated in the ANCHOR study, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met re-treatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Ranibizumab

1

Basel | N/A | Switzerland | 7.57327 | 47.55839

0

NCT00331864

[ 4 ]

98

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

null

Autistic Disorder

Serious behavioral problems in children and adolescents with AD Behavioral Problems

null

2

arm 1: Active Abilify arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks intervention 2: Tablets, Oral, once daily, 8 weeks

intervention 1: Aripiprazole intervention 2: Placebo

9

0

NCT00332241

[ 4 ]

214

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

null

Type II Diabetes Mellitus Dyslipidemia

Pitavastatin Type II Diabetes Mellitus Combined Dyslipidemia

null

2

arm 1: Pitavastatin 4 mg QD arm 2: Atorvastatin 40 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Pitavastatin 4 mg QD intervention 2: Atorvastatin 40 mg

intervention 1: Pitavastatin intervention 2: Atorvastatin

35

Aalborg | N/A | Denmark | 9.9187 | 57.048 Vejle | N/A | Denmark | 9.5357 | 55.70927 Vejle | N/A | Denmark | 9.5357 | 55.70927 Berlin-Spandau | N/A | Germany | N/A | N/A Chemnitz | N/A | Germany | 12.92922 | 50.8357 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Mainz | N/A | Germany | 8.2791 | 49.98419 Messkirch | N/A | Germany | 9.11479 | 47.99457 Bangalore | N/A | India | 77.59369 | 12.97194 Chennai | N/A | India | 80.27847 | 13.08784 Hyderabaad | N/A | India | N/A | N/A Hyderabaad | N/A | India | N/A | N/A Mumbai | N/A | India | 72.88261 | 19.07283 Breda | N/A | Netherlands | 4.77596 | 51.58656 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Leiden | N/A | Netherlands | 4.49306 | 52.15833 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Velp | N/A | Netherlands | 5.97361 | 51.995 Zoetermeer | N/A | Netherlands | 4.49306 | 52.0575 Bialystok | N/A | Poland | 23.16433 | 53.13333 Gruziadz | N/A | Poland | N/A | N/A Katowice | N/A | Poland | 19.02754 | 50.25841 Siedlce | N/A | Poland | 22.29006 | 52.16772 Tarnów | N/A | Poland | 20.98698 | 50.01381 Tychy | N/A | Poland | 18.96641 | 50.13717 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Łosice | N/A | Poland | 22.71801 | 52.21129 Berkshire | N/A | United Kingdom | N/A | N/A Lancashire | N/A | United Kingdom | N/A | N/A Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT00344370

[ 2 ]

37

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML.

This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute leukemias, high risk MDS, and CML who are not candidates for approved therapy. Over an 18-month period, the investigative sites collectively will enroll up to a total of 96 subjects. Subjects will be enrolled sequentially into 1 of 7 dose groups to evaluate 2 dosing schedules (Arm A = 14 consecutive days of dosing followed by a 7-28 day rest period as determined by recovery from any acute hematologic and non-hematologic toxicities, or Arm B = 28 consecutive days of dosing followed by a 7-28 day rest period, as determined by recovery from any acute hematologic and non-hematologic toxicities). The safety of a dose level in Arm A (14-day dosing regimen) will be established prior to enrollment of subjects in the same dose level in Arm B (28-day dosing regimen). In April 2007 the protocol was amended to discontinue Arm B (28 consecutive days of dosing). The protocol will continue as planned for Arm A (14 days of consecutive dosing). Enrollment will proceed until a maximum tolerated dose (MTD) has been established for each study Arm. Once the MTD has been reached, 12 additional subjects, with 1 or more of the hematologic conditions included in this study, may be enrolled at the MTD as an expanded safety cohort.

Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia

AML ALL MDS CML Kinase Inhibitor

null

1

arm 1: Treatment with ascending doses of KW-2449

[ 0 ]

1

[ 0 ]

intervention 1: Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).

intervention 1: KW-2449

4

0

NCT00346632

[ 3 ]

4

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.

OBJECTIVES: Primary * Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy. Secondary * Determine the progression-free, disease-free, and overall survival of patients treated with this regimen. * Determine the pattern of failure in patients treated with this regimen. * Evaluate the quality of life of patients treated with this regimen. * Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life. Tertiary * Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy. * Evaluate the quality of saliva by examining total protein concentrations. * Quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients. * Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy. * Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy. OUTLINE: This is a pilot study. * Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later. * Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks. * Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection. Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia. Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Head and Neck Cancer

oral complications of radiation therapy oral complications of chemotherapy mucositis xerostomia stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx

null

1

arm 1: Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.

[ 0 ]

7

[ 2, 2, 0, 0, 0, 3, 4 ]

intervention 1: subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses. intervention 2: If applicable on day 5, repeating every 3 weeks for 2 courses. intervention 3: Intravenous over 1 hour on day 1, every 3 weeks for 3 courses. intervention 4: Intravenous over 1 hour on day 1. intervention 5: Intravenous continuously on days 1-4. intervention 6: As appropriate, neck dissection. intervention 7: 60 Gy 5 days/week x 6 weeks with cisplatin

intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: cisplatin intervention 4: docetaxel intervention 5: fluorouracil intervention 6: conventional surgery intervention 7: radiation therapy

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00352118

[ 2 ]

36

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

null

Colorectal Cancer

null

1

arm 1: None

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: 7.5mg/kg iv (cycle 3 only) intervention 2: 130mg/m2 iv (cycles 1, 2 and 3) intervention 3: 1000mg/m2 po bid (cycles 1, 2 and 3)

intervention 1: Avastin intervention 2: Oxaliplatin intervention 3: capecitabine [Xeloda]

3

0

NCT00353262

[ 5 ]

349

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.

null

Pulmonary Disease, Chronic Obstructive

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: tiotropium intervention 2: Combivent (Ipratropium/Albuterol)

31

0

NCT00359788

[ 4 ]

1,385

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

true

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

null

Sexual Dysfunctions, Psychological

null

4

arm 1: 25 mg twice daily for 24 weeks arm 2: 50 mg taken once daily at bedtime for 24 weeks arm 3: 50 mg twice daily for 24 weeks arm 4: twice daily for 24 weeks

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Experimental: flibanserin 25 mg b.i.d intervention 2: Experimental: flibanserin 50mg qhs intervention 3: Experimental: flibanserin 50mg b.i.d. intervention 4: placebo

intervention 1: flibanserin intervention 2: flibanserin intervention 3: flibanserin intervention 4: placebo

81

0

NCT00360243

[ 4 ]

723

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Randomised, double-blind, double dummy, parallel group design. Following the screening period patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm from 2 mg up to the maintenance dose of 4 mg. Patients randomised to entacapone or placebo will have dummy up titrations to maintain the blind. Following this titration phase, patients will remain on the maintenance dose for a further 14 weeks. Patients will have visits at 2, 4, 6, 10, 14 and 18 weeks after baseline. A follow up visit will be performed at Week 22. A home diary will be completed in which patients rate themselves as either: 1. "OFF" 2. "ON" without dyskinesias 3. "ON" with non-troublesome dyskinesias 4. "ON" with troublesome dyskinesias 5. Asleep These entries will be completed every 30 minutes during the waking day and will be completed for three consecutive days immediately prior to visits at Baseline, Weeks 6, 10, 18 and 22. At Baseline (Day 0), week 10 and 18 the Unified Parkinson's Disease Rating Scale (UPDRS - Parts I, II , III and IV) will be performed. At the end of the treatment period (Week 18), patients will undergo final efficacy and safety assessments and will stop taking the study medication they were receiving. They will be seen 4 weeks later for a follow up visit.

null

Parkinson's Disease

null

3

arm 1: matching E2007 and matching entacapone arm 2: 2 mg once daily in the evening, Weeks 0→2 (2 weeks) and 4 mg once daily in the evening, Weeks 2→18. arm 3: 200 mg with each dose of Levodopa.

[ 2, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Placebo intervention 2: E2007 intervention 3: E2007

1

Toulouse | N/A | France | 1.44367 | 43.60426

0

NCT00360308

[ 4 ]

997

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

null

Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study. Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60). A home diary will be completed in which patients rate themselves as either: 1. OFF 2. ON without dyskinesia 3. ON with non-troublesome dyskinesias 4. ON with troublesome dyskinesias 5. Asleep These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.

null

Parkinson's Disease

null

1

arm 1: During the first two weeks of the study, Patients received 1 x 2mg E2007 tablet. At the week 2 visit, patients who tolerated the 2 mg/day dose were up-titrated to receive 4mg/day (2 x 2 mg E2007 tablets). Patients not tolerating the 4 mg dose were allowed to down titrate to 2 mg. Patients who did not tolerate the 2 mg dose were withdrawn from the study. Patients returned at week 4, if their tolerance to the 4 mg/day dose was acceptable they remained on this dose for the maintenance phase of the study. If at any time their tolerance declined, they were to return for an unscheduled visit and the daily dose was reduced to 2 mg. If at any stage, 2 mg day wass not tolerated, the patient was withdrawn from the study.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: E2007

1

Marburg | N/A | Germany | 8.77069 | 50.80904

0

NCT00360412

[ 4 ]

880

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

true

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Statistical Manual IV- Text Revision (DSM IV-TR®) criteria. Three hundred patients were to be randomized to each treatment group. This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks.

Sexual Dysfunctions, Psychological

null

3

arm 1: flibanserin 50 mg q.h.s. arm 2: flibanserin 100 mg q.h.s. arm 3: placebo q.h.s.

[ 0, 0, 2 ]

1

[ 0 ]

intervention 1: flibanserin placebo versus 50 mg qhs versus 100 mg qhs

intervention 1: flibanserin

54

0

NCT00360529

[ 0 ]

35

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women.

This will be a single center open label proof of concept study, recruiting subjects previously treated with Forteo for at least 12 months. A screening period of 3 to 6 weeks will precede the treatment period. At the baseline visit, patients whose eligibility is confirmed will be treated with ZA and followed for 12 months. Safety and efficacy will be assessed at regular intervals (day one, day 10, month 2, month 6, month 9 and month 12). Renal safety will be assessed prior to the i.v. dose of study medication, day 10 after the i.v. dose of study medication and at 12 months. Bone density at the lumbar spine (L1-4) and total hip will be performed at 6 months and at the end of the 12 month treatment period. Biomarker analyses for secondary endpoint will be performed for at day 10, month 2, month 6, month 9 and month 12.

Osteoporosis

osteoporosis zoledronic acid forteo

null

1

arm 1: 5 mg zoledronic acid in a single 15 minute IV

[ 0 ]

1

[ 0 ]

intervention 1: 5 mg zoledronic acid administered in a single 15 minute IV

intervention 1: zoledronic acid

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00361595

[ 3 ]

35

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or IIB (to T2) resectable Non-Small Cell Lung Cancer (NSCLC).

null

Non-Small Cell Lung Cancer Lung Cancer, Non-Small Cell

pazopanib I-ELCAP non-small cell lung cancer antiangiogenesis NSCLC GW786034

null

1

arm 1: 800 mg pazopanib oral daily

[ 0 ]

1

[ 0 ]

intervention 1: Pazopanib is an oral, potent, multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit. Subjects were to receive 800 mg oral pazopanib daily for a minimum of 2 weeks to a maximum of 6 weeks.

intervention 1: Pazopanib

12

0

NCT00367679

[ 5 ]

28

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

null

The objective of this study is to show that Ezetimibe will improve endothelial function following high cholesterol meals in healthy subjects by decreasing absorption of cholesterol and thus affecting concentration and composition of remnant-like particles.

24 subjects will be recruited. Exclusion criteria will be presence of known metabolic syndrome as well as history of coronary artery disease, hypertension, diabetes, cardiomyopathy and tobacco use. Study will be conducted as double blind placebo controlled crossover trial. Subjects will be randomized to 2 groups. 1st group will receive Ezetimibe for 2 weeks followed by washout (no medication) period for 4 weeks and followed by placebo for 2 weeks. 2nd group will receive Ezetimibe and placebo in reverse order with interspaced 4-week washout period. Each subject will be evaluated during 2 visits at the ends of the intervention periods (Ezetimibe and placebo). Visits will occur after 2 and 8 weeks after enrollment. Subjects will be asked to fast 12 hrs before each visit. During each visit, a subject will undergo brachial artery reactivity study (BART) before consumption of standardized high cholesterol meal and at 3 and 6-hour points after the meal. The standardized high cholesterol meal will consist of 2 Egg McMuffin® sandwiches. This meal weighs 276 g and contains 34g of protein, 60g of carbohydrates, 22g of total fat and 470 mg of cholesterol and has 290 Calories. Subjects also will have blood draws for serum lipid measurement performed before each BART procedure (total of 3 BART and 3 blood sample collections per patient per visit). Brachial artery reactivity studies will be conducted per following protocol: * Equipment - Echocardiography system w/vascular software for 2-D imaging, Doppler and high-frequency vascular transducer. * Initial image - Subject will be placed in a temperature-controlled room (22Cº). With subject positioned supine, left brachial artery will be imaged 5 cm above antecubital crease in longitudinal plane twice. Blood pressure and heart rate will be also measured. * FMD - 12.5 cm blood pressure cuff will be placed above the antecubital fossa on left arm, baseline flow velocity will be obtained by pulsed Doppler. Thereafter, artery will be occluded by cuff inflation to 50 mm Hg above systolic pressure for 5 minutes and subsequently deflated. The longitudinal image will be obtained 1 min after cuff release. * FMD w/NTG - 10 min after baseline study, FMD with NTG will be obtained. 0.4 mg sublingual NTG tablet will be given to subject and 4 min later, FMD imaging will be repeated as described above. * Analysis - Photographic images of end-diastolic frames will be obtained. Images will be analyzed by 2 independent investigators blinded to the subject's identity and temporal sequence of images. Arterial diameter of the brachial artery in longitudinal plane from images where there is clear visualization of anterior and posterior intimal/lumen interface will be determined by caliper measurement. FMD quantified as a percent diameter change of the post-occlusion arterial diameter measurement relative to the mean of the 2 corresponding baseline measurements. Similar analysis will be performed for FMD following administration of NTG. Lipid testing will be performed using the VAP® test and will include VLDL, LDL, HDL and IDL lipoprotein fractions as well as Triglycerides, Lipoprotein A, CRP and Homocysteine. Statistical analysis will be conducted as follows: group values for percent change in arterial diameter will be expressed as mean +/- SD. 2- tailed paired t-test will be used to compare changes in individual subjects. Two-tailed non-paired t-test will be used to compare values between groups. The analyses for FMD - lipid lowering correlation will be performed using a paired t test for parametrically distributed data and the Wilcoxon matched-pair signed rank test for nonparametrically distributed data to compare baseline data and changes in all variables at the end of the study within each group. The t test will used to compare the baseline characteristics between those receiving ezetimibe and those receiving placebo in all groups. Correlation between variables will be tested using both univariate and multitivariate analyses. The results will be presented as mean ± SD andmedian (25-75 percentiles).

Endothelial Dysfunction

null

2

arm 1: 1st group will receive Ezetimibe for 2 weeks followed by washout (no medication) period for 4 weeks and followed by placebo for 2 weeks. arm 2: 2nd group will receive Ezetimibe and placebo in reverse order with interspaced 4-week washout period.

[ 5, 5 ]

1

[ 0 ]

intervention 1: None

intervention 1: Ezetimibe

0

null

0

NCT00376246

[ 3 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage schedules are compared.

null

Carcinoma, Non-Small-Cell Lung

null

3

arm 1: Day 1 arm 2: Day 1, 2, and 3 arm 3: Day 1, 2, and 3

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: Intravenous Infusion

intervention 1: BI 2536

7

Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Gauting | N/A | Germany | 11.37703 | 48.06919 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Mainz | N/A | Germany | 8.2791 | 49.98419 Mainz | N/A | Germany | 8.2791 | 49.98419 Wiesbaden | N/A | Germany | 8.24932 | 50.08258

0

NCT00376623

[ 5 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.

Glaucoma

glaucoma diurnal intraocular pressure

null

1

arm 1: Cosopt twice daily in both eyes

[ 1 ]

1

[ 0 ]

intervention 1: Cosopt twice daily in both eyes

intervention 1: Cosopt

0

null

0

NCT00379834

[ 4 ]

450

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

null

Anxiety Disorders

Generalised Anxiety Disorder GAD

null

2

arm 1: Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. arm 2: Matching placebo tablets orally administered once daily.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period. intervention 2: Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.

intervention 1: Quetiapine XR intervention 2: Placebo

43

Fort Myers | Florida | United States | -81.84059 | 26.62168 Gainsville | Florida | United States | N/A | N/A Miami | Florida | United States | -80.19366 | 25.77427 Sarasota | Florida | United States | -82.53065 | 27.33643 Roswell | Georgia | United States | -84.36159 | 34.02316 Boston | Massachusetts | United States | -71.05977 | 42.35843 Brooklyn | New York | United States | -73.94958 | 40.6501 The Bronx | New York | United States | -73.86641 | 40.84985 Avon Lake | Ohio | United States | -82.0282 | 41.50532 Eugene | Oregon | United States | -123.08675 | 44.05207 Jenkintown | Pennsylvania | United States | -75.12517 | 40.09594 Austin | Texas | United States | -97.74306 | 30.26715 Houston | Texas | United States | -95.36327 | 29.76328 San Antonio | Texas | United States | -98.49363 | 29.42412 Tartu | Estonia | Estonia | 26.72509 | 58.38062 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Viljandi | N/A | Estonia | 25.59 | 58.36389 Bialystok | N/A | Poland | 23.16433 | 53.13333 Gorlice | N/A | Poland | 21.16035 | 49.65563 Katowice | N/A | Poland | 19.02754 | 50.25841 Krakow | N/A | Poland | 19.93658 | 50.06143 Leszno | N/A | Poland | 16.57494 | 51.84034 Skorzewo | N/A | Poland | 17.97006 | 54.16909 Torun | N/A | Poland | 18.59814 | 53.01375 Wroclaw | N/A | Poland | 17.03333 | 51.1 Arkhangelsk | N/A | Russia | 40.55291 | 64.54717 Izhevsk | N/A | Russia | 53.20448 | 56.84976 Lipetsk | N/A | Russia | 39.57076 | 52.60311 Moscow | N/A | Russia | 37.61556 | 55.75222 Nizhny Novgorod | N/A | Russia | 44.00205 | 56.32867 Perm | N/A | Russia | 56.25017 | 58.01046 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saratov | N/A | Russia | 46.00861 | 51.54056 Stavropol | N/A | Russia | 41.9734 | 45.0428 Voronezh | N/A | Russia | 39.1843 | 51.67204 Hlevakha | Kyiv Oblast | Ukraine | 30.32706 | 50.27423 Dnipro | N/A | Ukraine | 35.04066 | 48.46664 Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Luhansk | N/A | Ukraine | 39.30553 | 48.56814 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Vinnitsa | N/A | Ukraine | 37.71861 | 49.84639

0

NCT00389064

[ 4 ]

556

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

null

Hypertension

Hypertension, aliskiren, amlodipine, HCTZ, blood pressure

null

2

arm 1: None arm 2: None

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration intervention 2: All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration intervention 3: Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide

8

Santa Fe | New Mexico | United States | -105.9378 | 35.68698 Investigative Site | N/A | Belgium | N/A | N/A Investigative Center | N/A | Denmark | N/A | N/A Investigative Site | N/A | Finland | N/A | N/A Investigative Center | N/A | Germany | N/A | N/A Investigative Site | N/A | Iceland | N/A | N/A Investigative Site | N/A | India | N/A | N/A Investigative Site | N/A | Switzerland | N/A | N/A

0

NCT00402103

[ 5 ]

80

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg therapy.

null

Hepatitis B, Chronic Chronic Hepatitis B

Adefovir Dipivoxil(Hepsera) Chronic Hepatitis B (CHB)

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: adefovir dipivoxil 10mg

1

Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00403585

[ 4 ]

716

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER)

null

Allergic Rhinitis

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 5-mg Desloratadine tablet, once daily for 12 weeks intervention 2: Placebo tablet, once daily for 12 weeks

intervention 1: 5-mg Desloratadine intervention 2: Placebo tablet

0

null

0

NCT00405964

[ 5 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.

Retinal venous occlusive disease, which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), is second only to diabetic retinopathy as a cause of vision loss due to retinal disease. The main cause of vision loss in all of these disorders is the development of macular edema. Current clinical practice based on randomized controlled clinical trials (ETDRS, BVOS) employs laser photocoagulation, either in a focal or grid pattern, to treat macular edema associated with diabetic retinopathy and branch retinal vein occlusion. Unfortunately, laser photocoagulation is ineffective in central retinal vein occlusion (CRVO), and no proven therapy exists for CRVO. The pathogenesis of macular edema in retinal vascular diseases is generally accepted to be increased levels of vascular endothelial growth factor (VEGF) due to ischemic or other stimuli. VEGF is known to be one of the most potent stimulators of vascular leakage in humans. Therefore, it seems sensible to study inhibition of VEGF to reduce vascular leakage, reduce macular edema, and improve vision in these retinal vascular disorders. Phase 2 randomized, controlled clinical trials of Macugen in diabetic macular edema and in macular edema associated with CRVO have been conducted. In the diabetes trial, patients treated with Macugen had improved vision, reduced macular edema as measured by optical coherence tomography (OCT), and reduced need for laser treatment compared to patients treated with sham injections. In the CRVO trial, patients treated with Macugen 1 mg every 6 weeks for 24 weeks had improved vision and reduced macular edema at week 30 compared to sham. This is the first randomized trial of treatment for CRVO to show a benefit over control. Based on these positive findings, we plan to study Macugen treatment of macular edema due to BRVO.

Branch Retinal Vein Occlusion

branch retinal vein occlusion macular edema pegaptanib sodium vascular endothelial growth factor

null

2

arm 1: Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. arm 2: Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.

[ 1, 1 ]

1

[ 0 ]

intervention 1: Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3mg or 1mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48.

intervention 1: pegaptanib sodium (Macugen)

3

0

NCT00406107

[ 5 ]

245

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

null

Dyslipidemia Hypertension

null

4

arm 1: Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks. arm 2: Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo. arm 3: Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks. arm 4: Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .

[ 1, 0, 1, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Amlodipine besylate 5 mg intervention 2: Amlodipine/atorvastatin single pill combination 10/20 mg intervention 3: Amlodipine besylate 10 mg intervention 4: Amlodipine/atorvastatin single pill combination 5/20 mg

intervention 1: Amlodipine besylate intervention 2: Amlodipine besylate/atorvastatin calcium single pill combination intervention 3: Amlodipine besylate intervention 4: Amlodipine besylate/atorvastatin calcium single pill combination

51

0

NCT00412113

[ 2, 3 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.

Outline: This is a multi-center study. Chemotherapy/radiation therapy (2 cycles) * Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle * Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle * Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following: Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year. Patients with progressive disease will discontinue treatment. ECOG performance status 0 or 1 Hematopoietic: * Absolute neutrophil count (ANC) ≥ 1500 mm3 * Platelet count ≥ 100,000 mm3 * Hemoglobin ≥ 9 g/dL * PT or INR \< 1.5 x ULN unless on anti-coagulant therapy * PTT \< 1.5 x ULN unless on anti-coagulant therapy Hepatic: * Bilirubin ≤ 1.5 x ULN * ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) * AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) Renal: * Creatinine \< 1.5 X upper limit of normal (ULN) Cardiovascular: * No significant history of cardiac disease: Congestive heart failure \> class II NYHA. * Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy. Respiratory: * FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.

Non-Small Cell Lung Cancer

null

1

arm 1: Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer

[ 0 ]

4

[ 0, 0, 3, 0 ]

intervention 1: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle intervention 2: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle intervention 3: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) intervention 4: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months

intervention 1: Cisplatin intervention 2: Etoposide intervention 3: Radiotherapy intervention 4: Sorafenib

8

0

NCT00417248

[ 3 ]

10

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will determine whether an experimental drug called Rilonacept can improve artery function in patients with atherosclerosis, a disease in which fatty deposits in arteries cause the vessels to stiffen, impeding blood flow. Atherosclerosis is believed to be caused in part by inflammation. Rilonacept blocks production of a protein called CRP, which, in high levels in the blood is associated with increased inflammation. Patients with coronary artery disease who have elevated blood levels of CRP are at increased risk of heart attack, heart failure and sudden death compared with people who have lower levels of the protein. Patients 18 years of age and older with atherosclerotic coronary artery disease with a CRP level between 2 and 10 mg/L may be eligible for this study. Patients are randomly assigned to receive four doses of either Rilonacept or placebo, given at 2-week intervals as injections under the skin. In addition to treatment, patients undergo the following procedures during eight visits to the NIH Clinical Center: * Visit 1 (screening visit): Medical history, measurement of vital signs (temperature, blood pressure, heart rate and breathing rate), electrocardiogram (EKG) and blood tests. * Visit 2: Blood tests, chest X-ray, treadmill exercise testing, tuberculin skin test, brachial artery flow-mediated dilation. Brachial artery flow-mediated dilation is used to measure how well the brachial artery (artery inside the elbow) dilates. An ultrasound device placed just above the elbow measures the size of the brachial artery and the flow of blood through it before and after a pressure cuff is inflated around the forearm. * Visit 3: Injection of study drug. * Visits 4, 5, and 6: Review of any changes in health or medical treatment, measurement of vital signs, blood tests, EKG, injection of study drug. * Visit 7: Review of any changes in health or medical treatment, measurement of vital signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated dilation. * Visit 8: Review of any changes in health or medical treatment, measurement of vital signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated dilation.

Rilonacept (Interleukin-1 Trap) has been developed as an antagonist of the cytokine IL-1 in the treatment of rheumatoid arthritis and other inflammatory diseases. IL-1 causes leukocyte accumulation by inducing adhesion receptors on vascular endothelium and stimulating chemokine production. It also stimulates the synthesis of other cytokines, including IL-6, which in turn stimulates synthesis of C-reactive protein (CRP) in the liver. Based on numerous clinical studies, CRP has emerged as a risk marker for the development and clinical expression of atherosclerotic cardiovascular disease, leading to published recommendations for measurement of CRP in screening population subsets for cardiovascular risk. Endothelial function, as evidenced by stimulated nitric oxide release, has also been recognized as a marker of cardiovascular disease risk. Thus, patients with coronary artery disease (CAD) or its risk factors have impaired nitric oxide release from the endothelium compared with healthy subjects. Recent studies have shown that CRP levels were significantly higher in CAD patients compared with healthy subjects, with an inverse correlation between forearm blood flow responses to acetylcholine as a measure of endothelial function and CRP. Endothelial progenitor cells (EPCs) are primitive bone marrow-derived cells that have a capacity to home to sites of vascular injury and differentiate into vascular cell types, and are reduced in number and differentiation capacity in CAD patients relative to healthy subjects. Studies suggest that CRP inhibits viability and endothelial differentiation capacity of EPCs and may account for reduced numbers of EPCs and endothelial dysfunction in CAD patients. The objective of the present study is to demonstrate the potential of an investigational biological agent, rilonacept, as adjunctive treatment for CAD by examining effects of this agent on CRP levels, endothelial progenitor cell mobilization and endothelial function in a randomized, double-blind, placebo-controlled phase I/II clinical trial.

Coronary Artery Disease Atherosclerosis Inflammation Endothelial Dysfunction

Endothelium Inflammation Nitric Oxide Rilonacept Cytokines Coronary Artery Disease CAD Atherosclerosis

null

2

arm 1: Rilonacept 320 mg subcutaneous at each treatment visit arm 2: Normal saline subcutaneously at each treatment visit.

[ 0, 3 ]

2

[ 0, 0 ]

intervention 1: Lyophilized rilonacept will be supplied by Regeneron Pharmaceuticals at 160 mg/vial and reconstituted with 2.3 mL of sterile water for injection by the Clinical Center Pharmacy Intravenous Admixture Unit. The formulation contains 80 mg/mL rilonacept, histidine, citrate, PEG 3350, polysorbate 20, glycine, arginine, and sucrose (pH 6.5). Matching placebo in the identical formulation will also be supplied, and also reconstituted with 2.3 mL of sterile water for injection. Each administration of study drug will consist of two syringes containing 2.0 mL in each syringe (320 mg total drug). intervention 2: Normal saline subcutaneously at each treatment visit.

intervention 1: Rilonacept intervention 2: Placebo

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00417417

[ 4 ]

52

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate will be assessed at the end of the induction phase, and at the end of study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Lupus Nephritis

null

2

arm 1: Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID from Weeks 32 to 48. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48. arm 2: Participants received cyclophosphamide 0.75 grams per square meter (g/m\^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m\^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (mm\^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for subjects with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48 intervention 2: 0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48 intervention 3: 100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48 intervention 4: 0.75 g/m\^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m\^2 to maintain a minimum WBC count of ≥ 2500 per mm\^3 from Weeks 5 through 24

intervention 1: Mycophenolate Mofetil intervention 2: Corticosteroids intervention 3: Azathioprine intervention 4: Cyclophosphamide

11

Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Guangzhou | N/A | China | 113.25 | 23.11667 Guangzhou | N/A | China | 113.25 | 23.11667 Hangzhou | N/A | China | 120.16142 | 30.29365 Nanjing | N/A | China | 118.77778 | 32.06167 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shenyang | N/A | China | 123.43278 | 41.79222

0

NCT00425438

[ 3 ]

25

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will receive active study drug. The study will involve outpatient visits only. Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0 \[Visit 2\] through Week 12 \[Visit 7\]) followed by the Maintenance Phase (from Week 12 \[Visit 7\] to end of study).

null

Parkinson's Disease

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.

intervention 1: E2007

9

0

NCT00427011

[ 4 ]

274

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

2MALE

null

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

null

Hypogonadism

Hypogonadism Testosterone Deficiency

null

2

arm 1: Placebo arm 2: Testosterone (T) gel 1.62%

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient. intervention 2: Placebo Control

intervention 1: Testosterone (T) Gel 1.62% intervention 2: Placebo

0

null

0

NCT00433199

[ 3 ]

91

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study was to determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin (alfa or beta).

Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure. Erythropoiesis stimulating agents have been established as a treatment for anemia in subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor, and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents. Six dose cohorts of 15 participants each were evaluated in this study. Participants received peginesatide injection once every 4 weeks administered intravenously or subcutaneously for a total of 7 doses.

Anemia Chronic Kidney Disease Chronic Renal Failure

anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production

null

6

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

[ 0, 0, 0, 0, 0, 0 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment. intervention 2: Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment. intervention 3: Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment. intervention 4: Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment. intervention 5: Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment. intervention 6: Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.

intervention 1: peginesatide intervention 2: peginesatide intervention 3: peginesatide intervention 4: peginesatide intervention 5: peginesatide intervention 6: peginesatide

15

Burgas | N/A | Bulgaria | 27.46781 | 42.50606 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Veliko Tarnovo | N/A | Bulgaria | 25.62904 | 43.08124 Arad | N/A | Romania | 21.31667 | 46.18333 Bacau | N/A | Romania | 26.91384 | 46.56718 Bucharest | N/A | Romania | 26.10626 | 44.43225 Iași | N/A | Romania | 27.6 | 47.16667 Timișoara | N/A | Romania | 21.22571 | 45.75372 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00434330

[ 3 ]

17

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

Primary Objectives: * To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer * To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing Secondary objectives: * To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival * To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment Exploratory objective: * To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen. In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses).

Ovarian Cancer

Ovarian Cancer CA-125 Third-line Glufosfamide

null

3

arm 1: 1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle arm 2: 1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle arm 3: 1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Glufosfamide

10

0

NCT00442598

[ 5 ]

40

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffectiveness or side effects will be changed to ziprasidone and followed with detailed assessments for eight weeks. The hypothesis is that they will improve and have fewer side effects.

Ziprasidone has been found in studies and practice to be efficacious and tolerated well but has not been well studied or well accepted in the very severely ill in State Hospitals. This study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective disorder who require a change of medication because of poor response or unacceptable side effects. After signing consent and having a baseline assessment they will, if necessary, be reduced to one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can be increased to 240mg after three weeks if necessary. The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI), Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism (SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG and weight and blood metabolic measures. The hypothesis is that ziprasidone will be generally effective and that side effects especially metabolic indices will be reduced.

Schizophrenia Schizoaffective Disorder

Schizophrenia Ziprasidone

null

1

arm 1: Open label change to ziprasidone

[ 0 ]

1

[ 0 ]

intervention 1: Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks

intervention 1: ziprasidone

2

0

NCT00458211

[ 5 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.

null

Allergic Rhinitis

Allergic rhinitis

null

3

arm 1: None arm 2: None arm 3: None

[ 1, 1, 1 ]

1

[ 0 ]

intervention 1: None

intervention 1: Ciclesonide

1

Austin | Texas | United States | -97.74306 | 30.26715

0

NCT00458835

[ 3 ]

420

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

null

Irritable Bowel Syndrome With Constipation

Irritable Bowel Syndrome with Constipation IBS Irritable Bowel Syndrome linaclotide acetate linaclotide MD-1100

null

5

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

[ 1, 1, 1, 1, 2 ]

2

[ 0, 0 ]

intervention 1: Oral, once daily intervention 2: Oral, once daily

intervention 1: Linaclotide Acetate intervention 2: Matching placebo

85

0

NCT00460811

[ 5 ]

112

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.

null

Type 2 Diabetes Mellitus

Symlin Amylin insulin Humalog Novolog Apidra

null

2

arm 1: None arm 2: None

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals intervention 2: subcutaneous injection, dosing based on titration guidelines intervention 3: subcutaneous injection, dosing based on titration guidelines

intervention 1: pramlintide acetate (Symlin) intervention 2: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) intervention 3: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

37

0

NCT00467649

[ 2 ]

140

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

false

In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.

Please note that the present study is allocated two study phases, i.e. phase I and phase III.

Magnetic Resonance Imaging

Contrast-enhanced MRI MR angiography (MRA) Children 2-17 years

null

4

arm 1: Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection arm 2: Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection arm 3: Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection arm 4: Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection

[ 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection

intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

14

0

NCT00468819

[ 5 ]

480

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

null

Diabetes Diabetes Mellitus, Type 2

null

2

arm 1: None arm 2: None

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 2: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 3: Tablets, 2550 mcg. Administered once daily. intervention 4: Tablets 2 mg. 4, 6 or 8 mg administered once daily.

intervention 1: biphasic insulin aspart intervention 2: insulin glargine intervention 3: metformin intervention 4: glimepiride

69

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Ciudad Autonoma de Bs As | N/A | Argentina | N/A | N/A Ciudad Autónoma de BsAs | N/A | Argentina | N/A | N/A Mar del Plata | N/A | Argentina | -57.5562 | -38.00042 Bregenz | N/A | Austria | 9.7471 | 47.50311 Feldkirch | N/A | Austria | 9.6 | 47.23306 Traisen | N/A | Austria | 15.6 | 48.03333 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Brno | N/A | Czechia | 16.60796 | 49.19522 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 La Rochelle | N/A | France | -1.15222 | 46.16308 Limoges | N/A | France | 1.24759 | 45.83362 Mougins | N/A | France | 6.99523 | 43.60068 Narbonne | N/A | France | 3.00141 | 43.18396 Nevers | N/A | France | 3.159 | 46.98956 Pointe à Pitre | N/A | France | 1.98937 | 44.07984 Ahmedabad | Gujarat | India | 72.58727 | 23.02579 Karnāl | Haryana | India | 76.98448 | 29.69197 Bangalore | Karnataka | India | 77.59369 | 12.97194 Visakhapatnam | N/A | India | 83.20161 | 17.68009 Cheras | N/A | Malaysia | 101.726 | 3.108 Kota Bharu, Kelantan | N/A | Malaysia | 102.24333 | 6.12361 Pulau Pinang | N/A | Malaysia | 102.56667 | 3.55 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Pachuca | N/A | Mexico | -98.73329 | 20.11697 Almere Stad | N/A | Netherlands | 5.21413 | 52.37025 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Leiderdorp | N/A | Netherlands | 4.52917 | 52.15833 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Zoetermeer | N/A | Netherlands | 4.49306 | 52.0575 Manila | N/A | Philippines | 120.9822 | 14.6042 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Bialystok | N/A | Poland | 23.16433 | 53.13333 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Gdansk | N/A | Poland | 18.64912 | 54.35227 Gdynia | N/A | Poland | 18.53188 | 54.51889 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Lubin | N/A | Poland | 16.20149 | 51.40089 Lublin | N/A | Poland | 22.56667 | 51.25 Olsztyn | N/A | Poland | 20.49416 | 53.77995 Poznan | N/A | Poland | 16.92993 | 52.40692 Rzeszów | N/A | Poland | 21.99901 | 50.04132 Szczecin | N/A | Poland | 14.55302 | 53.42894 Warsaw | N/A | Poland | 21.01178 | 52.22977 Zabrze | N/A | Poland | 18.78576 | 50.32492 Satu Mare | Satu Mare County | Romania | 22.86255 | 47.79926 Botoșani | N/A | Romania | 26.66667 | 47.75 Bucharest | N/A | Romania | 26.10626 | 44.43225 Galati | N/A | Romania | 28.05028 | 45.43687 Târgovişte | N/A | Romania | 25.4567 | 44.92543 Kragujevac | N/A | Serbia and Montenegro | N/A | N/A Nis | N/A | Serbia and Montenegro | N/A | N/A Novi Sad | N/A | Serbia and Montenegro | N/A | N/A Bloemfontein | Free State | South Africa | 26.214 | -29.12107 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Brits | North West | South Africa | 27.78022 | -25.63473 Alzira | N/A | Spain | -0.43333 | 39.15 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Lund | N/A | Sweden | 13.19321 | 55.70584 Malmo | N/A | Sweden | 13.00073 | 55.60587 Stockholm | N/A | Sweden | 18.06871 | 59.32938

0

NCT00469092

[ 3 ]

226

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.

This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).

Diabetic Peripheral Neuropathy Neuralgia

DPN Diabetic Nerve Pain

null

2

arm 1: vehicle cream arm 2: active topical cream

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: topical cream applied daily for 4 weeks intervention 2: inactive placebo cream applied two times daily

intervention 1: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream intervention 2: placebo cream

1

New Delhi | N/A | India | 77.2148 | 28.62137

0

NCT00476151

[ 3 ]

49

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.

The study will be conducted at multiple centers. A total of 42 male and female panic disorder patients will be studied. The first 6 subjects will receive Staccato Alprazolam 1 mg open label to validate the dose selection. The remaining 36 subjects will be treated with either Staccato Alprazolam at the chosen dose; or with Staccato Placebo in a double blind, randomized order.

Treatment of Induced Panic Attack

Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam

null

4

arm 1: Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 2: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 3: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation arm 4: Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Inhaled Staccato Alprazolam Placebo intervention 2: Inhaled Staccato Alprazolam 1 mg intervention 3: Inhaled Staccato Alprazolam 2 mg intervention 4: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo

intervention 1: Inhaled placebo intervention 2: Inhaled alprazolam 1 mg intervention 3: Inhaled alprazolam 2 mg intervention 4: IV doxapram

3

0

NCT00477451

[ 4 ]

854

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

1FEMALE

false

The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.

Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503 IR compared with no drug (placebo) or one dose level of morphine (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain after abdominal hysterectomy. The study will include a blinded 72 hour in-patient phase immediately following hysterectomy, during which subjects will be treated with either 50-, 75-, or 100-mg CG5503 IR, a matched placebo, or 20-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 24 hours (using the mean SPID at 24 hours).

Hysterectomy Postoperative

Opioid Central acting analgesic Pain postoperative Abdomen acute CG5503 IR Morphine Placebo

null

5

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

[ 1, 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 20 mg IR; 4 - 6 hourly; Total 72 hours intervention 2: 50mg; 4 - 6 hourly; Total 72 hours intervention 3: 75mg; 4 -6 hourly; Total 72 hours intervention 4: 100mg, 4 - 6 hourly; Total 72 hours intervention 5: 4 - 6 hourly; Total 72 hours

intervention 1: Morphine intervention 2: CG5503 IR intervention 3: CG5503 IR intervention 4: CG5503 IR intervention 5: Placebo

52

Békéscsaba | N/A | Hungary | 21.1 | 46.68333 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Komárom | N/A | Hungary | 18.11913 | 47.74318 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Katowice | N/A | Poland | 19.02754 | 50.25841 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Lublin | N/A | Poland | 22.56667 | 51.25 Ruda Śląska | N/A | Poland | 18.85632 | 50.2584 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Brasov | N/A | Romania | 25.60613 | 45.64861 Brasov | N/A | Romania | 25.60613 | 45.64861 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Craiova | N/A | Romania | 23.8 | 44.31667 Ploieşti | N/A | Romania | 26.01667 | 44.95 Belgorod | N/A | Russia | 36.58015 | 50.61074 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Kragujevac | N/A | Serbia | 20.91667 | 44.01667 Novi Sad | N/A | Serbia | 19.83694 | 45.25167 Banská Bystrica | N/A | Slovakia | 19.15349 | 48.73946 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Martin | N/A | Slovakia | 18.92399 | 49.06651 Maribor | N/A | Slovenia | 15.64667 | 46.55472 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Zaporizhya | N/A | Ukraine | N/A | N/A

0

NCT00478023

[ 2, 3 ]

6

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

This study will test whether botulinum toxin (Botox) may relieve the uncomfortable sensations patients with restless legs syndrome (RLS) experience. RLS is a common movement disorder that causes sensory discomfort and restlessness, most often in the legs, which improves with movement. Although medications are available to treat the disorder, many people experience side effects that prevent them from continuing on the medication. The Food and Drug Administration has approved Botox for other movement disorders and for some cosmetic uses. People 18 years of age or older with moderate to severe RLS who have been taking RLS medications for more than 6 weeks before entering the study may be eligible to participate. Candidates are screened with a medical history, physical and neurological examinations, blood tests and, for women who can become pregnant, a urine pregnancy test. Participants are randomly assigned to receive injections of either Botox or placebo (salt water) into up to nine areas of the legs. The correct location of the muscles to be injected is determined by electromyography (EMG), a test that measures the electrical activity of muscles. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin. Needle EMG involves inserting a needle into a muscle. Both methods are used in this study. At 2 and 4 weeks after the injections, subjects are interviewed by telephone and asked to describe their symptoms, side effects and any improvement they may have noticed. After 12 weeks they return to NIH for injections with the alternate compound; that is, those who received Botox previously are given placebo for the second set of injections, and vice-versa. Subjects are again contacted by telephone 2 and 4 weeks after the injections to report their symptoms, side effects and benefits.

OBJECTIVE: To evaluate the efficacy of botulinum toxin type A, (BoNT) for the treatment of primary Restless legs syndrome (RLS). We hypothesize that BoNT will be effective at decreasing the deep sensory discomfort of RLS. STUDY POPULATION: This protocol is a proof of principle double-blind randomized placebo-BoNT crossover outpatient pilot study of 6 patients diagnosed with moderate to very severe primary RLS. DESIGN: All subjects will be evaluated at the NIH Clinical Center by a study investigator to determine eligibility for participation in this protocol. We will obtain a complete medical history, and perform a neurological examination, along with laboratory screening studies. Subjects eligible to participate will receive baseline ratings using the Restless Legs Rating Scale (RLS-RS). Subjects will then be randomized to receive electromyography (EMG)-guided injections of up to 90 units of BoNT or an equivalent volume of saline in each lower extremity, in symptomatic muscles. Subjects will then receive follow up ratings at week 2 and 4 following each injection. Twelve weeks after receiving the first injection, subjects will crossover to receive the alternative compound with similar follow up ratings. OUTCOME MEASURES: The primary outcome measure will be mean change from baseline at 4 weeks post-injection on the RLS-RS for placebo and BoNT, while the other pre specified outcomes will evaluate patient reported Clinical Global Impression of Change (CGI-C) scores for each group, duration of effect, and adverse events. Only descriptive statistics will be performed on this limited data sample.

Restless Legs Syndrome

Restless Leg Syndrome Botulinum Toxin RLS

null

2

arm 1: Injection of onabotulinumtoxinA arm 2: Injection of saline placebo

[ 0, 2 ]

1

[ 0 ]

intervention 1: Maximum dose of 90 units/leg was injected.

intervention 1: Botulinum Toxin A

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00479154

[ 3 ]

16

RANDOMIZED

CROSSOVER

4SUPPORTIVE_CARE

1SINGLE

false

0ALL

null

Commercially available external photoprotectors (EP) do not provide adequate protection against ultraviolet A (UVA) and visible wavelengths. The proposed medicinal product V0096 CR (formula RV3131A-MV1166) is a broad spectrum EP (bsEP). The rationale for the use of V0096 CR (formula RV3131A-MV1166) in the proposed condition is based on its ability to broadly block the UVA radiations and visible light that are known to trigger solar urticaria (SU).

null

Idiopathic Solar Urticaria

null

1

arm 1: Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window). Single application of the test materials at the dosage of 2mg/cm² (total of 8 treated sites), prior to irradiation using a solar simulator.

[ 0 ]

8

[ 0, 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

intervention 1: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209) intervention 2: Ti02 pigmentary 3% alone (formula RV3131A-MV1211) intervention 3: bisoctrizole 10% alone (formula RV3131A-MV1237) intervention 4: Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213) intervention 5: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329) intervention 6: Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212) intervention 7: Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)] intervention 8: V0096 CR vehicle (formula RV3131A-MV1197)

3

0

NCT00483496

[ 5 ]

7

RANDOMIZED

CROSSOVER

4SUPPORTIVE_CARE

3TRIPLE

true

0ALL

false

This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be done to confirm that there is a difference in pain experience.

Objective: 1\) To determine if tetracaine 4% gel (Ametop ®) reduces the pain of intramuscular palivizumab compared to placebo for pediatric patients between 1 month and 2 years of age. Rationale: Premedication with a systemic analgesic has not been shown to be effective in reducing the pain from an acute localized insult. EMLA and tetracaine have been shown to decrease pain associated with immunizations. EMLA requires a 60 minute application, which decreases the usefulness in a busy clinic. Tetracaine has a quicker onset of action and therefore may be more suitable for use in a busy clinic. Efficacy of tetracaine prior to palivizumab has not been reported and therefore it is not known if it can reduce the pain associated with intramuscular palivizumab injection. Setting: Respiratory synctial virus (RSV) clinic in the pediatric outpatient ward at Surrey Memorial Hospital. Procedure: A notice will be posted in the RSV clinic inviting parents to contact research staff if interested in participating in this study. When a parent contacts staff about the study, a nurse or pharmacist involved in the study will meet with the parent to review eligibility and obtain informed consent. Once informed consent obtained subject will be randomized by study pharmacist to receive either tetracaine 4% gel (Ametop®) or placebo before administration of the next palivizumab injection (study injection 1); a 4 block randomization design will be used. At the next injection (study injection 2) the subject will receive either tetracaine or placebo, whichever agent they did not receive at study injection 1. The subjects will serve as their own control. The placebo (Aquatain; Whitehall-Robins, Mississauga, Ontario, Canada) is visually and cosmetically similar to tetracaine 4% gel. One gram of drug or placebo will be dispensed in unit dose 5mL oral syringes, heat sealed to prevent evaporation and stored in a refrigerator for up to one week, after which it will be discarded if unused and redispensed. Tetracaine is commercially available in 1.5g tubes that produce approximately 1g tetracaine. On the day of immunization and on arrival to the clinic, a clinic nurse who is unaware of the treatment assignment will apply 1g of tetracaine or placebo to the subject's thigh and cover it with a dressing (opcit; Smith and Nephew). They will record the time of the application of the study gel. The clinic nurse will remove the dressing and study gel after 30-45 minutes and record the time of removal. The gel will be wiped from the skin with a paper tissue. A 4-point scale (none, mild, moderate, and severe) will be used to assess local skin reactions after removing study gel. Immediately before the injection the site will be cleaned with an alcohol swab, then the dose (15mg/kg using current weight) of palivizumab will be administered using a ½ - 5/8 inch 23-25 gauge needle. A RSV clinic nurse will inject palivizumab within several minutes of gel removal; clinic nurses will not be aware of the treatment assignment for the subjects. Study injection 1 and 2 will be video recorded. A mirror will be mounted so the video recorder can capture the subject's reaction both face on and from the mirror image. The videotape will continue until the subject calms down following the injection. The subject can be held by a parent during the injection and provide whatever usual comfort measures they would provide. Following the injection the parent will be asked questions to determine their interpretation of the subject's pain response to the injections and if there any factors that may affect the pain response. Once both study injections are completed the video will be reviewed and pain assessed for both injections by the same scorer using FLACC pain scale. The scorer will be one pediatric registered nurse who is competent in completing pain analysis for infants. The scorer will be blind as to which dose is tetracaine and which is placebo. Data Collection: The data collected will include the FLACC pain scale, parent assessment of patient's pain, factors affecting pain response, as well as identify adverse effects from tetracaine and placebo. Sample size and statistical Analysis: The number of subjects with informed consent will determine sample size. Statistical analysis will involve descriptive statistics only. Ethics: Confidentiality will always be maintained. No information as to the identify of the child will be placed on the data collection forms. Every child will be assigned a number to facilitate identification by the researchers. Informed consent will be obtained. Personnel: A team consisting of nurses, a physician, and a clinical pharmacist from SMH will conduct the study. All personnel are currently involved in the day-to-day management of these children and have the required expertise in carrying out this project. Timeline: The study will be submitted for ethical approval by the research ethics board, Fraser Health in April 2007. After approval anticipate patient enrolment to start in November 2007 and complete enrolment by March 2008. A further 4 months will be needed to analyze the data and prepare a manuscript. Expected completion date for the project is July 2008. Budget: No additional costs are expected for this study.

Pain

null

2

arm 1: Tetracaine 4% gel 1g applied to injection site arm 2: Placebo cream (Aquatain) 1g applied to inejction site

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: tetracaine applied prior to 1 injection intervention 2: placebo applied prior to 1 injection

intervention 1: tetracaine 4% gel intervention 2: Placebo

1

Surrey | British Columbia | Canada | -122.82509 | 49.10635

0

NCT00484393

[ 3 ]

210

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

null

Type 2 Diabetes Mellitus

Diabetes, Obese diabetics

null

2

arm 1: Phentermine 15mg/topiramate 100mg arm 2: Matched placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: phentermine 15mg/topiramate 100mg intervention 2: matched placebo

intervention 1: VI-0521 intervention 2: Placebo

9

0

NCT00486291

[ 5 ]

47

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.

This study consisted of two phases. In the Induction phase patients were randomized at Baseline 1 (BL1) in a 1:2 ratio to receive: * I1: HAART or * I2: Enfuvirtide (90 mg twice a day) + HAART. Participants who achieved viral suppression \< 50 copies/mL by week 24, confirmed by week 28 or earlier, qualified to enter the Maintenance Phase which started at Baseline 2 (BL2), four weeks after confirmation of response. The Maintenance Phase consisted of three treatment groups: * M1: HAART continued (patients from I1) Patients on ENF+HAART (I2) were re-randomized (at a 1:1 ratio) at BL2 to: * M2: Enfuvirtide stopped and HAART continued * M3: Enfuvirtide + HAART continued. The duration of the Maintenance Phase was from BL2 up to 48 weeks after BL1. BL2 could start at the earliest at Week 12 and at the latest Week 32.

HIV Infections

null

2

arm 1: Participants received Enfuvirtide (ENF) 90 mg administered by subcutaneous injection twice a day for up to 48 weeks in addition to an oral highly active antiretroviral treatment (HAART) regimen for up to 48 weeks. arm 2: Participants received an oral highly active antiretroviral treatment (HAART) regimen, consisting of 3-5 antivirals for up to 48 weeks.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 90 mg subcutaneous injection twice a day intervention 2: An oral HAART regimen of 3-5 antiretrovirals was chosen by the physician and patient, based on the patient's prior treatment history and genotypic antiretroviral resistance testing.

intervention 1: Enfuvirtide intervention 2: Highly active antiretroviral treatment (HAART)

39

Cleveland | Ohio | United States | -81.69541 | 41.4995 Austin | Texas | United States | -97.74306 | 30.26715 Dallas | Texas | United States | -96.80667 | 32.78306 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471 Nantes | N/A | France | -1.55336 | 47.21725 Paris | N/A | France | 2.3488 | 48.85341 Poitiers | N/A | France | 0.34348 | 46.58261 Villeneuve-sur-Lot | N/A | France | 0.70415 | 44.40854 Berlin | N/A | Germany | 13.41053 | 52.52437 Bonn | N/A | Germany | 7.09549 | 50.73438 Erlangen | N/A | Germany | 11.00783 | 49.59099 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Ramat Gan | N/A | Israel | 34.81065 | 32.08227 Bagno a Ripoli | N/A | Italy | 11.32252 | 43.75115 Bari | N/A | Italy | 16.86982 | 41.12066 Brescia | N/A | Italy | 10.21472 | 45.53558 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Tilburg | N/A | Netherlands | 5.0913 | 51.55551 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Cadiz | N/A | Spain | -6.2891 | 36.52672 Córdoba | N/A | Spain | -4.77275 | 37.89155 Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283 Huelva | N/A | Spain | -6.94004 | 37.26638 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Seville | N/A | Spain | -5.97317 | 37.38283 Valencia | N/A | Spain | -0.37966 | 39.47391 Zurich | N/A | Switzerland | 8.55 | 47.36667

0

NCT00487188

[ 5 ]

82

RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

true

Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery Participants: Patients having cataract surgery at UNC who meet eligibility criteria Procedures (methods): Patients will have pre and post-operative vision measured and optical coherence tomography (OCT) testing, also cataract density and intraoperative phacoemulsification parameters including ultrasound power and ultrasound time will be measured. Patients will be randomized into two groups. Group 1 will be treated with standard post-operative cataract management. Group 2 will be treated with standard post-operative cataract management plus topical nepafenac for one month. Post-operative macular thickness will be studied by analyzing the visual acuity and OCT measurements at two months post surgery.

We plan to enroll 80 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have pre-operative Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and pre-operative OCT (Humphrey-Zeiss Medical Systems, San Leandro, CA) in both eyes. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. Pre-operatively, all cataracts will be graded using the LOCS III classification system.10 Group 1 will receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation which is standard care for cataract surgery. Following surgery Group 1 will be treated with standard post operative cataract treatment, including a topical antibiotic and a topical corticosteroid. Group 2 will also receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation. Following surgery patients in Group 2 will be treated with topical nepafenac, a topical antibiotic, and a topical corticosteroid. Group 2 will be given the 3ml bottle of nepafenac to take home and instructed to use it three times per day for one month. Intra-operative surgical parameters including ultrasound time and average percent phacoemulsification power will be recorded for all surgeries. All patients will be seen on post-operative day one, one week, one month, and two months. At the two month visit, best corrected ETDRS vision and OCT will be repeated in both eyes. The two month visual acuity and post-operative OCT will be analyzed to evaluate the effect of nepafenac on CME following cataract surgery. Wilcoxon signed rank test will be used to compare pre-operative and post-operative differences between visual acuity and OCT measurements. The Spearman correlation will be used to compare the variables in the study including cataract density, ultrasound time, average percent phacoemulsification power, and OCT measurements.

Cystoid Macular Edema

cystoid macular edema cataract nonsteroidal antiinflammatory drugs optical coherence tomography

null

2

arm 1: topical antibiotic for 10 days and a topical corticosteroid for 1 month arm 2: 1 drop per study eye three times per day for 30 days in addition to standard care

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: topical antibiotic for 10 days plus topical corticosteroids for 1 month intervention 2: liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid

intervention 1: Standard Care intervention 2: nepafenac

1

Chapel Hill | North Carolina | United States | -79.05584 | 35.9132

0

NCT00494494

[ 4 ]

328

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.

null

Parkinson's Disease

null

1

arm 1: E2007 2 mg (one 2 mg tablet taken daily in the evening), or 4 mg (two 2 mg tablets daily in the evening).

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Perampanel

1

Toulouse | Toulouse Cedex | France | 1.44367 | 43.60426

0

NCT00505622

[ 3 ]

7

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Objective The objective of this study is to discover whether an infusion of nicardipine is able to reduce the time taken to achieve electrocerebral silence (ECS) during cardiopulmonary bypass (CPB) for aortic surgery. Hypothesis By inhibiting cold-induced cerebral vasoconstriction, nicardipine will maintain cerebral blood flow and allow more rapid cooling of the brain during CPB. This will manifest as a reduction in the time taken to achieve ECS and also as a reduction in overall CPB time.

Patients undergoing thoracic aortic surgery at Duke University Medical Center (DUMC) requiring hypothermic circulatory arrest (HCA) and neurophysiologic monitoring (NIOM) will give written informed consent and be enrolled into the study. Exclusion criteria will include previously documented allergy to nicardipine and age less than 18 years. Patients will then be randomized to one of two study groups: general anesthesia with or without nicardipine. Pre-operatively they will undergo clinical evaluation determined by the attending surgeon and anesthesiologist. During the pre-induction time period, all usual monitors and intravenous devices will be placed at the discretion of the attending anesthesiologist. In addition to the standard anesthetic monitors (Bispectral Index \[BIS\] and cerebral oximetry), transcranial Doppler (TCD) will be placed. Furthermore, the neurophysiology technician will place both standard EEG and somatosensory evoked potential (SSEP) electrode configurations. During the pre-induction time period, midazolam use will be at the discretion of the anesthesiologist but will be limited to a maximum dose of 0.1 mg/kg; other benzodiazepines will not be allowed. Opioid (fentanyl) administration will be at the discretion of the anesthesiologist. Total benzodiazepine and opioid doses will be recorded and converted to midazolam and fentanyl equivalents for subsequent analysis. When ready, patients will be transported into the operating room and anesthesia will be induced. Induction will consist of propofol (1 - 5 mg/kg single intravenous bolus), fentanyl and vecuronium for neuromuscular blockade. Other drugs and dosages of opioids and neuromuscular blockers are at the discretion of the anesthesiologist. After induction and tracheal intubation, patients will receive maintenance anesthesia of 0.5 minimal alveolar concentration (MAC) isoflurane in a 50% air/oxygen balanced mixture supplemented with fentanyl at the discretion of the anesthesiologist. At the onset of cardiopulmonary bypass (CPB), study drug (nicardipine or equivalent volume of placebo - 0.9% saline) infusion at 5 mg/hr will be initiated, and patients will receive 0.5 MAC isoflurane in the CPB circuit sweep gas. Bolus doses of 100mcg phenylephrine will be administered to both groups in order to maintain a constant mean arterial pressure of at least 50 mmHg. Cooling will occur primarily through the CPB machine. When the patient's brain temperature reaches 28o C, isoflurane (via the pump) will be reduced to 0.25 MAC. When ECS on EEG and ablation of cortical responses on SSEP have both occurred, CPB and study drug infusion will be halted, and thoracic aortic surgery will be commenced. After aortic repair has occurred, CPB and study drug infusion at 5 mg/hr will be reinstated, anesthesia administration resumed, and the patient actively rewarmed. When the patient's brain temperature reaches 28o C (as recorded by nasopharyngeal temperature), patients will receive 0.5 MAC isoflurane. After the patient has been fully re-warmed and is ready for separation from CPB, study drug infusion will be halted. At this point, but not before, commercially available nicardipine may be infused if so desired. 10 ml blood samples will be drawn from the pump at baseline and 15 minute intervals thereafter until HCA is achieved. When the pump is restarted, further samples will be drawn at 15 minute intervals until the patient separates from CPB after which no further samples will be taken. One sample of 10 ml will be drawn from the retrograde cardioplegia line immediately after placement (baseline) and one sample will be drawn immediately prior to separation from CPB. In total, approximately 100 ml of blood will be drawn from the patient for research purposes. This volume represents a tiny percentage of the excess volume associated with the pump prime, and is insignificant in terms of its effect on hemodynamics. Baseline patient characteristics will be collected in the pre-operative period and will include age, sex, weight, height, blood pressure, heart rate, temperature, comorbidities, type of aortic disease, and American Society of Anesthesiologists (ASA) grade. Prior to initiation of CPB, several factors will be recorded including arterial blood pressure, heart rate, cerebral oximetry, bispectral index score (BIS), latency \& amplitude of SSEP, frequency of EEG background, cerebral blood flow assessed by middle cerebral artery (MCA) velocity on TCD, and nasopharyngeal temperature. During cooling, BIS scores, cerebral oximetry, and MCA velocity by TCD will be noted for each 0.5o C decrement in nasopharyngeal temperature; the duration from CPB initiation to 3 characteristic EEG changes (1. rhythmic delta, 2. Generalized periodic epileptiform discharge (GPED), 3. burst suppression) as defined by the neurophysiologist, the duration from CPB initiation to 2 characteristic SSEP changes (1. latency increase of \>10%, 2. amplitude decrease of 50% from baseline), and hemodynamics at each 1o C nasopharyngeal temperature drop will also be recorded. At the time of HCA, several factors will be documented including nasopharyngeal temperature, duration from CPB initiation (the primary endpoint measure), total opioid doses, cerebral oximetry, BIS score, MCA velocity by TCD, hemodynamics. During rewarming, factors will be documented in the same fashion and at the same intervals as during cooling. At the first attempt at separation from CPB, documented factors will include BIS score, cerebral oximetry, MCA velocity by TCD, duration from CPB reinstitution to first attempt at separation, total dose of study drug, nasopharyngeal temperature, and hemodynamics. Finally, in addition to any Adverse Events (AEs) that may have occurred, data relating to length of ICU stay, length of hospital stay, in-hospital mortality, in-hospital acute kidney injury (defined as a 50% rise from baseline in serum creatinine, and of at least 0.3 mg/dl or need for dialysis), in-hospital stroke, in-hospital myocardial infarction, and discharge disposition from hospital (home, skilled nursing facility, other institution) will be recorded postoperatively. With the exception of the on-pump blood draws, in this protocol there are no additional procedures or safety measures indicated or necessary for the purpose of research only. All anesthetic regimens and monitoring techniques are currently standard of care. Nicardipine infusion is currently widely used during cardiac anesthesia and post-operative cardiac recovery.

Aortic Aneurysm, Thoracic

Aortic Arch Reconstruction Surgery

null

2

arm 1: Nicardipine arm 2: 0.9% saline

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: on bypass intervention 2: on bypass

intervention 1: Nicardipine intervention 2: 0.9% saline

1

Durham | North Carolina | United States | -78.89862 | 35.99403

0

NCT00508118

[ 3, 4 ]

58

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).

It has been found that people who consume a large amount of oily fish tend to have a lower risk of developing colon cancer. This is thought to be due to the omega-3 fatty acids present in oily fish, one of which is EPA. The effect of taking a 99% pure form of EPA (2g per day) compared with placebo capsules on the number and size of polyps in the rectum over a six month period will be investigated. FAP is an inherited susceptibility to diffuse colorectal adenomas and colorectal carcinoma, occurring in close to 100% of unresected colons. It is caused by a germline mutation in the Adenomatous Polyposis Coli (APC) gene located in the long arm of chromosome 5. To prevent cancer development it is recommended that patients with FAP undergo colectomy with ileo-anal or ileo-rectal anastomosis (or colectomy and end-ileostomy) at a socially convenient time before polyp progression to malignancy and before the age of 25. Patients with the attenuated FAP phenotype, often associated with mutations at the 5' terminus (exon 4 and proximally), have fewer polyps and may often delay colectomy. Patients with an ileo-rectal anastomosis are still susceptible to polyp formation in the remaining rectal stump and require 6 monthly check-ups with a flexible sigmoidoscope with removal of any polyps that develop. Therefore, an effective chemopreventative agent with a favourable side-effect profile would be of benefit to FAP patients with ileo-rectal anastomosis (IRA) and recurrent rectal polyps in addition to young adults who prefer to delay colectomy. If such an agent were to be effective in FAP patients in the prevention of colonic polyps, it may also be of benefit to the larger population of patients with sporadic colorectal adenomatous polyps who are also at risk of colorectal cancer. Colorectal polyps are thought, at least in part, to arise from an imbalance in the levels of cell proliferation and apoptosis (natural cell death) in the colonic mucosa. It has been suggested that omega-3 polyunsaturated fatty acids (PUFAs) in fish oil can manipulate the high levels of colonic-mucosal cell proliferation rates associated with colonic adenomas. The rationale for this trial is based on the increasing evidence linking inflammatory processes and the development of a number of cancers, including bowel cancer. This has focused attention on the role of inflammatory mediators in the development of cancer. In particular, the family of eicosanoids (including 2-series prostaglandins, 4-series leukotrienes and thromboxanes) produced through conversion of the omega-6 PUFA, arachidonic acid, via cyclo-oxygenase-2 (COX-2) is believed to contribute to the physiological processes of inflammation and the development of tumours. Prostaglandin E2, a product of the conversion of arachidonic acid via the COX-2 pathway, has been implicated in tumourigenesis through: 1. promotion of angiogenesis 2. anti-apoptotic properties 3. increasing expression of matrix metalloproteinases and hence the ability of a tumour cell to undergo metastasis 4. altering the cytokine expression profile of cells. The class of eicosanoid synthesised will depend on the PUFA substrate. Whilst arachidonic acid is converted to 2-series prostaglandins and 4-series leukotrienes, EPA is converted to 3-series prostaglandins and 5-series leukotrienes. Overall, the latter eicosanoids are less potent as inflammatory mediators than those derived from arachidonic acid. Increasing daily intake of EPA, the omega-3 PUFA analogue of arachidonic acid, alters the balance between the cell content of these fatty acids. This results in reduced production of the more active inflammatory/tumourigenic products of arachidonic acid metabolism. This is supported by the results of recent work at St George's Hospital Medical School, London. In patients with a history of colonic adenomas, daily dosing with a highly purified, free-fatty acid form of the EPA produced a significant reduction in cell proliferation and increase in apoptosis in the colonic mucosa. This preparation of EPA has the proprietary name "Alfa" and is referred to here as EPA. This proposed study will be based upon the randomised, placebo-controlled National Cancer Institute sponsored study in which three groups of FAP patients were assigned to one of two doses of celecoxib (a COX-2 inhibitor) or placebo. The results showed a reduction in the polyp burden of the group taking the higher (400mg twice daily (bd)) dose. However, there is evidence to suggest that COX-2 inhibitors carry significant potential for side-effects. Adopting a similar design, EPA will be substituted for celecoxib in this randomised, placebo-controlled trial, comparing 2g EPA to placebo, with reduction in polyp burden as the primary objective.

Familial Adenomatous Polyposis Coli FAP

Eicosapentaenoic Acid EPA EPA 99% Fatty acid omega-3 apoptosis cell proliferation colonic mucosa polyp Familial Adenomatous Polyposis Coli FAP resolvin Ileo-rectal anastomosis IRA PUFA Endoscopy

null

2

arm 1: Eicosapentanenoic Acid (EPA) as the free fatty acid 2 capsules twice daily for 6 months. Endoscopy and biopsies taken as described under intervention. arm 2: Medium chain triglycerides 2 capsules twice daily for six months. Endoscopy and biopsies taken as described under intervention.

[ 0, 2 ]

4

[ 0, 3, 3, 0 ]

intervention 1: 2 x 500mg EPA capsules twice daily for 6 months intervention 2: Endoscopy with video and photographs at baseline and month 6. intervention 3: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy). intervention 4: 2 x 500mg placebo capsules twice daily for 6 months

intervention 1: Eicosapentanoic Acid (EPA) intervention 2: Endoscopy intervention 3: Biopsies taken intervention 4: Placebo

1

Harrow | Middlesex | United Kingdom | -0.33208 | 51.57835

0

NCT00510692

[ 4 ]

2,152

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

true

1FEMALE

false

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.

null

Contraception

null

2

arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year). intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).

intervention 1: NOMAC-E2 intervention 2: DRSP-EE

0

null

0

NCT00511199

[ 2 ]

70

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.

null

Type 2 Diabetes Mellitus

null

2

arm 1: None arm 2: None

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose \[TD\] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments. Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2. intervention 2: 10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c. intervention 3: LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin

intervention 1: MK-0941 intervention 2: Placebo intervention 3: LANTUS insulin

0

null

0

NCT00511472

[ 2 ]

70

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

null

Type 2 Diabetes Mellitus

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day intervention 2: Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

intervention 1: MK0941 intervention 2: Comparator: Placebo

0

null

0

NCT00511667

[ 4 ]

9

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old.

This is a Phase III, multicenter, open-label study, which will quantify the improvement of nutrient absorption when participants are receiving Ultrase® MT20. The improvement will be demonstrated by comparing the CFA percent (%) and CNA% obtained during a washout of enzyme with the CFA% and CNA% obtained during a period of treatment with Ultrase® MT20. The study is also designed to obtain safety data in CF children suffering also from PI taking Ultrase® MT20. The total duration for the participation of children in this study will be approximately up to 38 days and will include 3 phases: screening phase, the washout phase and treatment phase. Screening phase: this phase will last 15 days and all participants will take Ultrase® MT20 as per investigator's discretion during this period. During the last 4 days, participants will be stabilized on a high fat diet and with Ultrase® MT20. The individual 'stabilized dose' of Ultrase® MT20 capsules will be determined for each participant based on the average number of capsules of Ultrase® MT20 taken during last 4 days. Washout phase: this phase will last 6 to 7 days. The participants will continue the high-fat diet but will refrain from taking Ultrase® MT20 or any other enzymes. A 72-hour stool collection will be performed and all food consumed by the participants will be recorded to assess the CFA% and CNA%. Treatment phase: this phase will last 7 to 11 days. The participants will continue the high-fat diet and will take the 'stabilized dose' of Ultrase® MT20 established during screening. Another 72-hour stool collection will be performed and all food consumed by the participants will be recorded to assess the CFA% and CNA%.

Cystic Fibrosis Pancreatic Insufficiency

Cystic Fibrosis Pancreatic insufficiency Steatorrhea Children 7 to 11 years Pancreatic enzyme

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Ultrase® MT20 capsules will be administered orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants will receive high-fat diet and Ultrase® MT20 dose will be adjusted depending on symptoms of steatorrhea. This will be followed by a washout phase of 6 to 7 days, in which participants will receive only high-fat diet; then stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) will be administered orally for 7 to 11 days during treatment phase. The stabilized dose should not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).

intervention 1: Ultrase® MT20

3

0

NCT00513682

[ 4 ]

8

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients with low disease activity (Disease Activity Score 28 \[DAS28\] \>2.8 and \<3.5) is being conducted to evaluate induction of remission by adding infliximab to pre-existing treatment versus no additional treatment. All subjects eligible for this study, aged \>35 to \<=65 years, will have a diagnosis of RA according to American College of Rheumatology (ACR) criteria, and will be offered additional treatment with infliximab. Prior to the start of treatment, subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at least 3 months. Subjects will be randomized (1:1) to basic therapy with or without infliximab for a total duration of 38 weeks followed by a follow-up period of up to 6 months. Subjects randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6, 14, 22, 30, and 38. The primary objective of the study is to assess the rate of remission according to DAS 28 (\<2.6) at the end of treatment (after 38 weeks). Safety assessments include the incidence of adverse events, serious adverse events, and clinically notable abnormal vital signs and laboratory values.

null

Rheumatoid Arthritis

null

2

arm 1: 3 mg/kg infliximab plus basic treatment arm 2: Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs \[DMARDs\])

[ 0, 1 ]

2

[ 2, 0 ]

intervention 1: infliximab 3 mg/kg and basic treatment intervention 2: Methotrexate (15 - 25 mg/week); chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89

intervention 1: infliximab intervention 2: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.

0

null

0

NCT00521924

[ 4 ]

185

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.

null

Hypertension

Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Stage I and II Hypertension

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: Tablets intervention 2: Tablets

intervention 1: Amlodipine intervention 2: Olmesartan medoxomil plus amlodipine

18

0

NCT00527514

[ 3 ]

45

null

FACTORIAL

0TREATMENT

0NONE

false

0ALL

false

The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD

null

Attention Deficit Hyperactivity Disorder

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks

intervention 1: Atomoxetine

12

Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Fukushima | N/A | Japan | 140.46667 | 37.75 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ishikawa | N/A | Japan | 127.82139 | 26.42333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Kyoto | N/A | Japan | 135.75385 | 35.02107 Nara | N/A | Japan | 135.80485 | 34.68505 Saitama | N/A | Japan | 139.65657 | 35.90807 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00530335

[ 4 ]

165

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

null

Hypertension Hypercholesterolemia

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 1, 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Single pill combination, dosed once daily for 8 weeks intervention 2: Single pill combination, dosed once daily for 8 weeks intervention 3: Single pill combination, dosed once daily for 8 weeks intervention 4: Single pill combination, dosed once daily for 8 weeks

intervention 1: Amlodipine 2.5mg/Atorvastatin 5mg intervention 2: Amlodipine 2.5mg/Atorvastatin 10mg intervention 3: Amlodipine 5mg/Atorvastatin 5mg intervention 4: Amlodipine 5mg/Atorvastatin 10mg

17

0

NCT00530946

[ 4 ]

742

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

null

Bronchial Asthma

Asthma Symbicort

null

3

arm 1: Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily arm 2: Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily arm 3: Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily intervention 2: Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily intervention 3: Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

intervention 1: Symbicort Turbuhaler intervention 2: Symbicort pMDI intervention 3: Pulmicort Turbuhaler

48

Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Benesov U Prahy | N/A | Czechia | N/A | N/A Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Jihlava | N/A | Czechia | 15.59124 | 49.3961 Kladno | N/A | Czechia | 14.10285 | 50.14734 Kolín | N/A | Czechia | 15.1998 | 50.02806 Kutná Hora | N/A | Czechia | 15.26816 | 49.94839 Litoměřice | N/A | Czechia | 14.1318 | 50.53348 Neratovice | N/A | Czechia | 14.51759 | 50.25926 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Rokycany | N/A | Czechia | 13.59459 | 49.7427 Strakonice | N/A | Czechia | 13.90237 | 49.26141 Balassagyarmat | N/A | Hungary | 19.29614 | 48.07296 Budapest | N/A | Hungary | 19.04045 | 47.49835 Cegléd | N/A | Hungary | 19.79952 | 47.17266 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Deszk | N/A | Hungary | 20.24322 | 46.21802 Győr | N/A | Hungary | 17.63512 | 47.68333 Gyula | N/A | Hungary | 21.28333 | 46.65 Kaposvár | N/A | Hungary | 17.8 | 46.36667 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539 Szarvas | N/A | Hungary | 20.55 | 46.86667 Százhalombatta | N/A | Hungary | 18.93878 | 47.32949 Szeged | N/A | Hungary | 20.14824 | 46.253 Törökbálint | N/A | Hungary | 18.91356 | 47.42931 Bialystok | N/A | Poland | 23.16433 | 53.13333 Bielsko-Biala | N/A | Poland | 19.04686 | 49.82245 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Chodzież | N/A | Poland | 16.9198 | 52.99505 Chrzanów | N/A | Poland | 19.40203 | 50.13546 Karpacz | N/A | Poland | 15.75594 | 50.77669 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Ostrów Wielkopolski | N/A | Poland | 17.80686 | 51.65501 Poznan | N/A | Poland | 16.92993 | 52.40692 Skierniewice | N/A | Poland | 20.15837 | 51.95485 Szczecin | N/A | Poland | 14.55302 | 53.42894 Tarnów | N/A | Poland | 20.98698 | 50.01381 Turek | N/A | Poland | 18.50055 | 52.01548 Wodzisław Śląski | N/A | Poland | 18.47205 | 50.00377 Wroclaw | N/A | Poland | 17.03333 | 51.1 Łomża | N/A | Poland | 22.05935 | 53.17806

0

NCT00536731

[ 3 ]

392

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

null

Asthma

QMF indacaterol Twisthaler®

null

6

arm 1: Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 2: Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 3: Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 4: Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 5: Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 6: Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

[ 0, 0, 0, 0, 1, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device). intervention 2: Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. intervention 3: Placebo TWISTHALER® device intervention 4: Placebo AEROLIZER® device intervention 5: 100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

intervention 1: indacaterol intervention 2: formoterol intervention 3: placebo to indacaterol intervention 4: placebo to formoterol intervention 5: short acting β2-agonist

60

Aalst | N/A | Belgium | 4.0355 | 50.93604 Halen | N/A | Belgium | 5.11096 | 50.94837 Oostham | N/A | Belgium | 5.17877 | 51.10374 Veurne | N/A | Belgium | 2.66803 | 51.07316 Boskovice | N/A | Czechia | 16.65997 | 49.48751 Brno | N/A | Czechia | 16.60796 | 49.19522 Břeclav | N/A | Czechia | 16.88203 | 48.75897 Liberec | N/A | Czechia | 15.05619 | 50.76711 Most | N/A | Czechia | 13.63617 | 50.50301 Tábor | N/A | Czechia | 14.6578 | 49.41441 Aalen | N/A | Germany | 10.0933 | 48.83777 Berlin | N/A | Germany | 13.41053 | 52.52437 Braunschweig | N/A | Germany | 10.52673 | 52.26594 Deggendorf | N/A | Germany | 12.96068 | 48.84085 Fürstenwalde | N/A | Germany | 14.06185 | 52.36067 Leipzig | N/A | Germany | 12.37129 | 51.33962 München | N/A | Germany | 13.31243 | 51.60698 Balassagyarmat | N/A | Hungary | 19.29614 | 48.07296 Érd | N/A | Hungary | 18.91361 | 47.39489 Füzesabony | N/A | Hungary | 20.41667 | 47.75 Gyonggyos | N/A | Hungary | N/A | N/A Mosdoz | N/A | Hungary | N/A | N/A Pest | N/A | Hungary | 19.08333 | 47.5 Siófok | N/A | Hungary | 18.058 | 46.90413 Százhalombatta | N/A | Hungary | 18.93878 | 47.32949 Afula | N/A | Israel | 35.2892 | 32.60907 Ashkelon | N/A | Israel | 34.57149 | 31.66926 Beersheba | N/A | Israel | 34.7913 | 31.25181 Haifa | N/A | Israel | 34.99928 | 32.81303 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Rehovot | N/A | Israel | 34.81199 | 31.89421 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Tel-Hashorner | N/A | Israel | N/A | N/A Zrifin | N/A | Israel | N/A | N/A Bialystok | N/A | Poland | 23.16433 | 53.13333 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Lodz | N/A | Poland | 19.47395 | 51.77058 Lubin | N/A | Poland | 16.20149 | 51.40089 Tarnów | N/A | Poland | 20.98698 | 50.01381 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Smolensk | N/A | Russia | 32.04371 | 54.77944 Tomsk | N/A | Russia | 84.98204 | 56.50032 Bloernfontain | N/A | South Africa | N/A | N/A Cape Town | N/A | South Africa | 18.42322 | -33.92584 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Krugersdorp | N/A | South Africa | 27.77515 | -26.08577 Les Marais | N/A | South Africa | N/A | N/A Pretoria | N/A | South Africa | 28.18783 | -25.74486 Roodepoort | N/A | South Africa | 27.8725 | -26.1625 Themba | N/A | South Africa | 28.26438 | -25.38171 Madrid | N/A | Spain | -3.70256 | 40.4165 Pozuelo de Alacron | N/A | Spain | N/A | N/A Valencia | N/A | Spain | -0.37966 | 39.47391 Downpatrick | N/A | United Kingdom | -5.71529 | 54.32814 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 London | N/A | United Kingdom | -0.12574 | 51.50853 Southampton | N/A | United Kingdom | -1.40428 | 50.90395 Watford | N/A | United Kingdom | -0.39602 | 51.65531

0

NCT00545272

[ 3 ]

31

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.

null

Asthma

Asthma, QMF149, fixed combination of indacaterol and mometasone furoate

null

2

arm 1: In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days. arm 2: In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device. intervention 2: Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device. intervention 3: Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

intervention 1: indacaterol maleate/mometasone furoate intervention 2: placebo to indacaterol maleate/mometasone furoate intervention 3: fluticasone proprionate / salmeterol xinafoate

2

Poitiers | N/A | France | 0.34348 | 46.58261 Berlin | N/A | Germany | 13.41053 | 52.52437

0

NCT00556673

[ 3 ]

37

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.

null

Asthma

Asthma QMF Indacaterol Mometasone

null

3

arm 1: In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period. arm 2: In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period. arm 3: In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period.

[ 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI. intervention 2: Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device. intervention 3: Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device. intervention 4: Placebo to fluticasone propionate / salmeterol delivered via MDDPI.

intervention 1: fluticasone propionate/salmeterol intervention 2: indacaterol maleate / mometasone furoate intervention 3: placebo to indacaterol/mometasone intervention 4: placebo to fluticasone propionate/salmeterol

6

Aalst | N/A | Belgium | 4.0355 | 50.93604 Ghent | N/A | Belgium | 3.71667 | 51.05 Berlin | N/A | Germany | 13.41053 | 52.52437 Hanover | N/A | Germany | 9.73322 | 52.37052 Landsberg | N/A | Germany | 12.16076 | 51.52698 Rostock | N/A | Germany | 12.14049 | 54.0887

0

NCT00557440

[ 2 ]

78

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

null

Diabetes Mellitus, Type 2

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: BI 10773 low dose intervention 2: placebo to BI 10773 intervention 3: BI 10773 medium dose intervention 4: BI 10773 high dose

3

Berlin | N/A | Germany | 13.41053 | 52.52437 Mainz | N/A | Germany | 8.2791 | 49.98419 Neuss | N/A | Germany | 6.68504 | 51.19807

0

NCT00558571

[ 0 ]

28

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms will also be assessed.

See brief summary

Schizophrenia

Schizophrenia Pregnenolone Cognition Negative Symptoms

null

2

arm 1: Pregnenolone arm 2: Placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks intervention 2: Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks

intervention 1: Pregnenolone intervention 2: Placebo

1

Durham | North Carolina | United States | -78.89862 | 35.99403

0

NCT00560937

[ 3 ]

12

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.

null

Primary Peritoneal Carcinoma Tumor Epithelial Ovarian Cancer Uterine Disease Cervix Diseases Neoplasms, Ovarian Cancer

AGO Advanced, Gynaecologic cancer(s), Genetics GW786034, Pazopanib,

null

2

arm 1: Oral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m\^2 IV over three hours day one q 3 weeks for six cycles arm 2: Oral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitaxel 175 mg/m\^2 IV over three hours day one q 3 weeks for six cycles

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 800 mg orally once a day for 6 cycles intervention 2: IV over one hour every 3 weeks of 6 cycles intervention 3: IV 175 mg/m\^2 given over 3 hours on day one of a 21 day cycle for six cycles

intervention 1: pazopanib (GW786034) intervention 2: carboplatin intervention 3: paclitaxel

5

0

NCT00561795

[ 2 ]

18

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation.

null

Type 2 Diabetes Mellitus

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state intervention 2: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal intervention 3: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast intervention 4: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state

intervention 1: 10 mg MK-0941 DFC (fasted) intervention 2: 10 mg MK-0941 OCT (after meal) intervention 3: 10 mg MK-0941 OCT (before meal) intervention 4: 10 mg MK-0941 OCT (fasted)

0

null

0

NCT00567112

[ 3 ]

34

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The goal of this clinical research study is to learn if azacitidine can help to control MF. The safety of azacitidine in patients with Myelofibrosis (MF) will also be studied.

Azacitidine is a drug that is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better. If you are found to be eligible to take part in this study, you will be able to begin treatment with azacitidine. You will receive azacitidine as an injection under the skin once a day for 7 days in a row. This will be repeated every 4 weeks (4 weeks equals 1 cycle). The first cycle of azacitidine will be given at M. D. Anderson, in an outpatient setting. Later cycles of treatment courses may be given at M. D. Anderson or by a cancer doctor in your community. You may receive up to 12 cycles of treatment if you are responding well to treatment. You will be taken off study if your disease gets worse or intolerable side effects occur. Once you go off study, you will receive follow-up as is standard of care for your disease. This is an investigational study. Azacitidine is FDA approved for the treatment of myelodysplastic syndrome. Its use in this study is experimental. A total of up to 34 patients will take part in this study. All will be enrolled at M. D. Anderson.

Myelofibrosis

Myelofibrosis MF Leukemia Azacitidine Vidaza

null

1

arm 1: 75 mg/m\^2 Subcutaneous Daily for 7 days every 4 weeks

[ 0 ]

1

[ 0 ]

intervention 1: 75 mg/m\^2 subcutaneous daily for 7 days (every 4 week cycle)

intervention 1: Azacitidine

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00569660

[ 5 ]

28

NA

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

true

Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients. Consensus guidelines recommend using medications such as heparin or low-molecular-weight heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a fixed dose that is the same for everyone. The appropriate dose of medication in patients with severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in severely obese patients may not provide adequate protection against DVT. The purpose of this study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once daily in severely obese patients will lead to predictable blood levels.

Background and Introduction: Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in hospitalized patients. It is a well-known complication in patients after major surgery or trauma. More recently, medically ill patients have been identified as another high risk group with up to 15% of patients experiencing VTE in the absence of prophylaxis. 1 Several studies have found the use of enoxaparin, dalteparin, and fondaparinux to be safe and effective in reducing risk of VTE by 45% to 63% in medically ill patients. 1-3 Additionally, enoxaparin has been found to be at least as safe and effective as unfractionated heparin for VTE prophylaxis. 4 Enoxaparin 40 mg once daily has been shown to be a safe and effective prophylactic therapy in hospitalized patients. 1 In thromboprophylaxis studies, including those investigating enoxaparin 40 mg once daily, morbidly obese patients (greater than or equal to 35 kg/m2) have been grossly under-enrolled. This is problematic for several reasons. First, the drug distribution is weight dependent and therefore, anticoagulant levels will differ according to a patient's weight. 5 Secondly, the FDA approved doses are fixed doses that do not take into account body weight. Thirdly, obese patients are at greater risk for failure in preventing VTE and obese patients are probably at greater risk for developing VTE. 6 Lastly, morbidly obese patients are becoming quite common as the population as a whole is becoming more obese. Even with this information, there are no standards of VTE prophylaxis in obese patients. Optimal means of delivering safe and effective thromboprophylaxis in this group is unknown. When using LMWH's, consensus recommendations have been to monitor peak anti-Xa activity targeting a level of 0.1-0.2 units/mL. 5 However, many hospitals do not have access to anti-Xa monitoring. Studies evaluating the predictability of weight-based prophylactic dosing of tinzaparin have demonstrated that anti-Xa levels are predictably achieved and therefore, laboratory monitoring may not be necessary with this dosing strategy.7 However, tinzaparin is not widely utilized in the U.S. and uncertainties remain about whether predictable anti-Xa levels can be achieved with a weight-based prophylactic regimen using the more commonly used drug enoxaparin. If weight-based dosing with enoxaparin is shown to result in predictable anti-Xa activity in obese patients, the need for monitoring would be obviated. Objectives: The primary objective is to evaluate the predictability in achieving target anti-Xa activity levels in morbidly obese medically ill patients using weight-adjusted (0.5 mg/kg) once daily prophylactic dose of enoxaparin. The secondary objective is to gain information to evaluate the pharmacokinetic curve of enoxaparin in obese patients over 18 hours after the second dose. Participant Selection Criteria: VTE risk will be evaluated with an institutionally utilized risk stratification scheme. This risk stratification scheme which was drafted by a multi-disciplinary panel, represents standard of care for medically ill patients at the University of Utah. Inclusion Criteria: Medically ill patients who are greater than 18 years of age who have a body mass index (BMI) greater than or equal to 35 kg/m2 who are admitted to the University of Utah Medical Center, are at risk for VTE, and are eligible for pharmacological prophylaxis as determined by patient's provider will be consented for the study. Exclusion Criteria: Patients who are pregnant (a urine HCG will be performed if a female of child-bearing age is not on reliable birth control, or if otherwise clinically indicated), are currently on therapeutic anticoagulation, have a bleeding disorder, platelet count of less than 100,000/mL, coagulopathy, active bleeding, creatinine clearance less than 30 mL/min (based on Cockcroft-Gault equation, and rounding serum creatinine to 1 in patients greater than 65 years), or recent (within 14 days) stroke, surgery or trauma will be excluded. Design: This is a single arm study enrolling consecutive eligible patients admitted to the University of Utah Medical Center. This is a descriptive study evaluating the feasibility and predictability of administering weight-adjusted enoxaparin (0.5mg/kg once daily) to achieve recommended target peak anti-Xa levels in patients at extreme body weight. The hypothesis is that weight-adjusted prophylaxis will reliably achieve recommended target anti-Xa levels. If so, this would obviate the future need for routine anti-Xa monitoring using this pharmacologic regimen. Additionally, there will also be a parallel cohort evaluating a day 2 pharmacokinetic curve by 5-serial anti-Xa activity measurements in a subset of up to 2-3 patients in each weight group. Study procedures: Consecutive eligible patients will be enrolled if informed consent is given. Consent will be obtained in the University Hospital, mainly on the Internal Medicine Floor. It will be obtained by the one of the study co-investigators. At least one person who is obtaining consent will be available to consent patients any time of day and will have adequate time to exchange information and answer questions between investigator and participant. The study protocol uses a VTE prevention regimen that employs rational pharmacologic principles and is in line with published recommendations for prophylaxis in this patient population. In consideration of having a comparator cohort group, we would consider it to be unethical to have a cohort group receiving enoxaparin 40 mg subcutaneously once daily as a comparator group because pharmacologic data strongly suggests that effective levels of anticoagulation would not be achieved in this population of patients. 8 Informed consent was felt optimal in order to allow patients to fully understand that this regimen, although it is an acceptable standard of care, is being employed under the broader context of a study whereby other patient data will be collected and recorded in prospective fashion. Once informed consent is obtained, patients will begin VTE prophylaxis with enoxaparin 0.5 mg/kg subcutaneously once a day. Peak anti-Xa activity will be obtained in all patients through a venipuncture 4-6 hours after the first or second dose has been given. Five milliliters of blood will be drawn. This is the amount of blood that is needed for this laboratory test to be performed. Baseline clinical and demographic information will be obtained and recorded on standard case reporting forms, CRF (see Appendix B). Patients will continue prophylaxis as deemed necessary by their attending physician through the duration of their hospital stay or unless dictated otherwise by the patient's attending physician. Adverse events such as VTE, bleeding event, or thrombocytopenia will be recorded during the hospital stay (see Appendix C). If patients consent to do the additional testing, this will be marked on the consent form. These patients will have anti-Xa levels drawn before the first enoxaparin dose, and then at 4h, 6h, 12h, and 18h after the second dose of enoxaparin. If the 12h anti-Xa level is obtained and is less than 0.05 units/mL, then the 18 hour blood test can be eliminated. The purpose of this section is to provide us with information to evaluate the pharmacokinetic curve of enoxaparin in obese patients over 18 hours.

Obesity Venous Thrombosis Anticoagulants

Obesity venous thrombosis Anticoagulants

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.

intervention 1: Enoxaparin 0.5 mg/kg once daily

1

Salt Lake City | Utah | United States | -111.89105 | 40.76078

0

NCT00585182

[ 5 ]

130

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Rush University Medical Center, Chicago, IL.

null

Type 2 Diabetes

type 2 diabetes inpatient hyperglycemia SQ insulin Hospitalized patients with type 2 diabetes

null

2

arm 1: Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously arm 2: NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Detemir insulin SQ once daily + aspart insulin SQ before meals intervention 2: NPH insulin SQ + regular insulin SQ before breakfast and dinner

intervention 1: Detemir + aspart insulin before meals intervention 2: NPH insulin + regular insulin

2

0

NCT00590226

[ 3 ]

28

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.

null

Asthma

Asthma spirometry lung function serum cortisol serum potassium plasma glucose

null

2

arm 1: Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days. arm 2: Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device. intervention 2: Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

intervention 1: indacaterol maleate / mometasone furoate intervention 2: placebo to indacaterol maleate/mometasone furoate

3

Neuil | N/A | France | 0.51155 | 47.17219 Paris | N/A | France | 2.3488 | 48.85341 Poitiers | N/A | France | 0.34348 | 46.58261

0

NCT00605306