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

[ 3 ]

29

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Primary Objective: To evaluate efficacy and safety of ITF2357 in the treatment of patients with JAK2V617F positive myeloproliferative diseases \[Polycythemia Vera (PV), Essential Thrombocytosis (ET), Myelofibrosis (MF)\]. Efficacy was evaluated by ad hoc haematological and clinical criteria for PV and ET, and by internationally established response criteria (EUMNET criteria) for MF. Safety was evaluated by number of subjects experiencing an Adverse Event (AE), type, frequency, severity, timing and relatedness of AEs, including changes in vital signs and clinical laboratory results. Secondary Objective: To evaluate the JAK2 mutated allele burden by quantitative Real-Time Polymerase Chain Reaction (qRTPCR).

This is a non-randomized, open-label, Phase IIA pilot study testing efficacy and safety of ITF2357 in a population of patients with JAK2V617F positive myeloproliferative diseases. All recruited patients received an initial dose of 50 mg b.i.d. of ITF2357 that was subsequently escalated to 50 mg t.i.d. in case of lack of significant toxicity. Treatment lasted up to a maximum of 24 cumulative weeks of drug administration. The study was carried out in Italy. Enrolled patients were subjects of both genders, with an established diagnosis of polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF) according to the revised WHO criteria.

Myeloproliferative Diseases

polycythemia vera (PV) essential thrombocythemia (ET) myelofibrosis (MF)

null

1

arm 1: Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.

[ 0 ]

1

[ 0 ]

intervention 1: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.

intervention 1: ITF2357

2

Bergamo | N/A | Italy | 9.66721 | 45.69601 Pavia | N/A | Italy | 9.15917 | 45.19205

0

NCT00606307

[ 5 ]

13

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

We are trying to learn if small changes in the amount of a valproate in the blood (given through an IV) will change the way the brain reacts to flashing lights.

Photosensitive epilepsy is a form of epilepsy that is considered to have a genetic basis in most instances. It is a reflex type of epilepsy. Patients with this condition exhibit epileptic activity patterns (called photoparoxysmal response-PPR) on their EEG during intermittent photic stimulation with certain flash frequencies. Specific Aims 1. To determine the extent of the pharmacodynamic effect of small changes in total and free VPA concentration via constant infusion of intravenous sodium valproate within the same photosensitive epilepsy patient. 2. To determine the change in total and free VPA concentration required to achieve maximal effect on PPR in patients with photosensitive epilepsy. Hypothesis 1. Valproic acid (VPA) demonstrates differential pharmacodynamic effect on PPR with small changes in VPA concentration (5-20 mg/L changes in total, or 0.5 to 2 mg/L changes in free VPA) within the same patient. In essence, the VPA concentration-response curve in patients with photosensitive epilepsy is relatively steep. 2. Intravenously-administered VPA will demonstrate a reduction in standard photosensitive range (SPR) or abolition of PPR for at least 80% of patients studied, when the entire range of free VPA concentrations is considered. Photosensitivity, defined as a PPR on intermittent photic stimulation (IPS), is found in approximately 5% of all epileptic patients. Markedly photosensitive patients are usually sensitive to IPS within clearly defined limits of flash frequency (mostly between 10-30 Hz). This photosensitivity range, the difference between the highest and lowest flash rates that consistently elicit a photoparoxysmal response (PPR), can be used as a quantitative measure of photosensitivity. Administration of some antiepileptic drugs (AEDS) can diminish or even abolish PPR. With a standard set of tested frequencies, a standard photosensitive range (SPR) can be used to measure drug effect on photosensitivity. Combined with blood level monitoring, the model offers information about actual pharmacodynamic effect as measured with IPS related to the changes in blood levels. The standardized IPS procedure includes delivery of short (5 second-) trains of flashes. The stimulation starts with the lowest frequencies (which usually do not produce a PPR) only up to the limits of the photosensitivity range (the threshold frequencies for which the patient shows an epileptiform EEG response). After that the stimulation starts again with the highest frequencies (which also do not produce a PPR) down to the frequency that produces a definite PPR. The photic stimulator will be manually controlled for all stimulations in order to abort the stimulation when a clear PPR is elicited. With all stimulations, there is simultaneous recording of the EEG and direct observation of the patient for clinical changes. With all the safety measures in place, the likelihood of provoking prominent clinical seizures is extremely low.

Photosensitive Epilepsy

epilepsy photosensitive valproic acid

null

1

arm 1: all patients will have placebo on day 1 and VPA infusion on day 2

[ 0 ]

2

[ 0, 0 ]

intervention 1: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003). intervention 2: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.

intervention 1: Valproic Acid intervention 2: Placebo

2

0

NCT00609245

[ 3 ]

17

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. To aggressively treat this cancer this study uses effective drugs in three parts: * Induction ends on day 19 * Consolidation ends on day 38 or 42 * Maintenance may include up to 6 cycles

null

Non-Hodgkin's Lymphoma

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: LSA4 intervention includes three phases: induction, consolidation and maintenance

intervention 1: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00610883

[ 3 ]

48

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

true

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.

OBJECTIVES: Primary * To determine the rate of clinical benefit (complete response \[CR\], partial response \[PR\], and stable disease \[SD\] in patients with hormone-dependent locally recurrent or metastatic breast cancer treated with letrozole in combination with erlotinib hydrochloride. Secondary * To determine the time to progression (TTP) in patients treated with this regimen. * To evaluate the anti-tumor activity, as determined by CR and PR rates, of this regimen in these patients. * To evaluate the safety of this regimen in these patients. * To determine if tumors that are positive for epidermal growth factor receptor (EGFR) or Ser118 ER, or that overexpress human epidermal receptor (HER2) exhibit a longer TTP from the combination compared to tumors that do not express or overexpress these molecules. OUTLINE: This is a multicenter study. Patients are stratified according to prior hormone therapy (hormone-therapy naive/first-line therapy vs prior hormonal therapy with either tamoxifen or an aromatase inhibitor in the adjuvant or metastatic setting/second-line therapy) Patients receive oral letrozole and oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.

Breast Cancer

recurrent breast cancer stage IV breast cancer

null

2

arm 1: None arm 2: None

[ 0, 0 ]

5

[ 0, 0, 6, 10, 10 ]

intervention 1: OSI-774 150 mg/day intervention 2: Letrozole 2.5 mg/day intervention 3: To determine HER2 gene amplification or excess copies of the HER2 gene intervention 4: to measure the epidermal growth factor receptors (EGFR) intervention 5: To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs

intervention 1: erlotinib hydrochloride intervention 2: letrozole intervention 3: fluorescence in situ hybridization intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis

9

0

NCT00611715

[ 3 ]

257

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

null

Acne Vulgaris

null

4

arm 1: Doxycycline dosed at 40 mg/day to subjects of appropriate weights arm 2: Doxycycline dosed at 80 mg/day to subjects of appropriate weights arm 3: Doxycycline dosed at 160 mg/day to subjects of appropriate weights arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: doxycycline 40 mg/day, oral, 12 weeks intervention 2: doxycycline 80 mg/day, 12 weeks intervention 3: doxycycline 160 mg/day, 12 weeks intervention 4: Placebo, 12 weeks

intervention 1: Doxycycline 0.6 mg/kg/day intervention 2: Doxycycline 1.2 mg/kg/day intervention 3: Doxycycline 2.4 mg/kg/day intervention 4: Placebo

23

0

NCT00612573

[ 4 ]

169

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

null

Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled

null

4

arm 1: In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 2: In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study. arm 3: In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study. arm 4: In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.

[ 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Indacaterol 150 μg or 300 μg, delivered via SDDPI intervention 2: Tiotropium 18 μg once daily delivered via inhalation device intervention 3: Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)

intervention 1: Indacaterol intervention 2: Tiotropium intervention 3: Placebo

20

Camperdown | N/A | Australia | 151.17642 | -33.88965 Gauting | N/A | Germany | 11.37703 | 48.06919 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Mainz | N/A | Germany | 8.2791 | 49.98419 Marburg | N/A | Germany | 8.77069 | 50.80904 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Almelo | N/A | Netherlands | 6.6625 | 52.35667 Breda | N/A | Netherlands | 4.77596 | 51.58656 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Harderwijk | N/A | Netherlands | 5.62083 | 52.34167 Helmond | N/A | Netherlands | 5.66111 | 51.48167 Wellington | N/A | New Zealand | 174.77557 | -41.28664 Katowice | N/A | Poland | 19.02754 | 50.25841 Warsaw | N/A | Poland | 21.01178 | 52.22977 Durban | N/A | South Africa | 31.0292 | -29.8579 A Coruña | N/A | Spain | -8.396 | 43.37135 Alicante | N/A | Spain | -0.48149 | 38.34517 Cacenes | N/A | Spain | N/A | N/A Madrid | N/A | Spain | -3.70256 | 40.4165 Ourense | N/A | Spain | -7.86407 | 42.33669

0

NCT00615459

[ 3 ]

456

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Generalized Anxiety Disorder

Anxiety

null

3

arm 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg arm 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg arm 3: Placebo total daily dose 0.9 mg

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg intervention 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg intervention 3: Placebo total daily dose 0.9 mg

intervention 1: eszopiclone intervention 2: eszopiclone intervention 3: Placebo

57

0

NCT00616655

[ 3 ]

73

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).

null

Moderate or Severe Submental Fullness

null

6

arm 1: Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 3: Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 4: Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 5: Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 6: Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

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

2

[ 0, 0 ]

intervention 1: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. intervention 2: None

intervention 1: Deoxycholic Acid Injection intervention 2: Placebo

7

0

NCT00618618

[ 4 ]

343

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

false

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Issues on safety will be addressed in Adverse Events section.

Central Nervous System Diseases

Central Nervous System Imaging Diagnostic Imaging

null

1

arm 1: Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.

[ 0 ]

1

[ 0 ]

intervention 1: Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.

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

37

0

NCT00623467

[ 1 ]

12

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

false

0ALL

false

Summary: A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the induced sputum of atopic asthmatics following inhalation of allergen. Hypothesis: Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the airway lumen in atopic asthmatics during the timeframe of the late asthmatic response. Objective: The objective of this study is to examine the kinetics of dendritic cells in induced sputum following allergen challenge in atopic asthmatic subjects.

Subjects will be put through two study periods. Each study period will consist of four visits and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening procedures, including complete history and physical examination. In addition, methacholine inhalation challenge and skin-prick testing will be preformed to assess airway hyper-responsiveness and determine atopic status respectively. Lastly, sputum will be induced before challenge (0 hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7 hours following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood. Before the next study period begins, there will be a washout period of 2-4 weeks. On the first visit of the second study period, a methacholine challenge will be performed to ensure the return of PC20 to within one doubling dose of baseline values. Also, sputum will be induced before challenge (0hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7hrs following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.

Asthma

asthma atopy allergen challenge sputum myeloid and plasmacytoid dendritic cells

null

2

arm 1: Inhalation challenge preformed with diluent. arm 2: Inhalation challenge preformed with allergen.

[ 2, 1 ]

1

[ 0 ]

intervention 1: None

intervention 1: Aeroallergen

1

Hamilton | Ontario | Canada | -79.84963 | 43.25011

0

NCT00625989

[ 4 ]

602

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

null

Reflux Esophagitis

null

3

arm 1: Esomeprazole 20mg arm 2: Esomeprazole 40mg arm 3: Omeprazole 20mg

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 20mg once daily intervention 2: 40 mg once daily intervention 3: 20mg once daily

intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Omeprazole

41

0

NCT00633932

[ 3 ]

261

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.

null

Hypertension

Hypertension High Blood Pressure

null

5

arm 1: Irbesartan 300 mg once daily arm 2: Blinded Placebo Treatment arm 3: PS433540 200mg once daily arm 4: PS433540 400mg once daily arm 5: PS433540 800mg once daily

[ 1, 2, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 300 mg (2 x 150 mg capsules) once daily for 12 weeks intervention 2: placebo capsules once daily for 12 weeks intervention 3: 200 mg (2 x 100 mg capsules) once daily for 12 weeks intervention 4: 400 mg (4 x 100 mg capsules) once daily for 12 weeks intervention 5: 800 mg (8 x 100 mg capsules) once daily for 12 weeks

intervention 1: irbesartan intervention 2: placebo intervention 3: PS433540 intervention 4: PS433540 intervention 5: PS433540

40

0

NCT00635232

[ 5 ]

1,570

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.

Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia. Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s. This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.

Pain

pain opioid abuse moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.

intervention 1: morphine sulfate extended release capsules

384

0

NCT00640042

[ 1 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA) approval for use of pregabalin in nerve pain associated with diabetes and shingles; making it the first FDA-approved treatment for both of these nerve pain states. Tremor is uncontrolled trembling in part of the body. Essential tremor (ET) is associated with purposeful movement(e.g., holding a glass to drink, shaving, writing and buttoning a shirt). It occurs most often in the hands and head and also may affect the arms, voice box (larynx), trunk, and legs. ET is caused by abnormalities in areas of the brain that control movement. It usually does not result in serious complications. ET affects approximately 5 million people in the United States. Incidence is highest in people over the age of 60. ET usually develops gradually during middle age or later in life. Symptoms may remain mild or become more severe over time. Stress, fatigue, anxiety, and hot or cold weather can worsen the disorder. Severe tremor may cause difficulty doing activities of daily living, such as: * Brushing hair and teeth * Holding a glass without spilling * Performing self-care (e.g., getting dressed, shaving, putting on makeup) * Using eating utensils * Writing and drawing The purpose of this pilot/feasibility study is to examine the tolerability and efficacy of Pregabalin in patients with ET. In other words, can patients diagnosed with ET tolerate high dose of pregabalin? Will the pregabalin be considered as an efficient medicine in the treatment of ET?

Overview We propose a single site, double-blind, placebo-controlled, cross-over design. Drug will be administered in 75mg capsules with a target dose of 300 mg/day. Pregabalin will be titrated upward as described in the "Summary of Schedule" table with flexibility. During weeks 3-5 and 12-14, the investigator will have the option of increasing the study drug from 2 capsules per day (150 mg vs. placebo) to 3 or 4 capsules per day if no benefit is noted. If the dose is increased, it must be done so at a rate of 150mg/day/week. Patients who can not tolerate a higher dose will be allowed to drop back to a previously tolerated dose but must be on that dose for one week prior to evaluation. After treatment and clinical assessment, study drug will be decreased by 150mg/day every 2 days until discontinuation. This pertains to both the wash out phase and at the end of the study. Both adverse events and need for drug titration will be conducted during the safety call. Identical assessments will be done at baseline and at the end of the treatment period for both drug and placebo. Half of the subjects (group A) will initiate with placebo and then crossover to drug. The other half (group B) will start treatment with pregabalin and then crossover to placebo. The primary endpoint will be the change in Fahn-Tolosa-Marin Tremor Rating Scale (TRS) from baseline. Scale has Parts A= (severity of rest, action \& postural tremor in upper and lower extremities, face, voice, tongue, head \& trunk), B= (severity of tremor writing, drawing \& pouring), C= (functional disability while speaking, eating, drinking, maintaining hygiene, dressing \& working) and the total summed. Other clinical assessments will include Clinical Global Impression of Change (CGI-C), Quality of Life in Essential Tremor Questionnaire (QUEST) maximum score =100, Hamilton Anxiety Scale (HAM-A) score 0-17 = mild, 18-24 = moderate, and 25-30 moderate to severe, and a sleep hygiene questionnaire rating across 5 domains- physical symptoms, energy \& motivation, concentration, interpersonal relations, and psychological symptoms (HD-16). For the TRS, HAM-A, QUEST, and HD-16 higher scores represent increased symptom severity or diminished quality of life and the CGI-C is scored as follows: 1=very much improved, 2=much improved, 3= mildly improved, 4=no change, 5= mildly worse, 6= much worse, and 7=very much worse.

Essential Tremor

Essential tremor Activities of Daily Living (ADL's)

null

2

arm 1: Pregabalin (Lyrica) 75 mg bid to a maximum dose of 300 mg bid arm 2: Placebo to 4 capsules bid

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 75 mg bid to 300 mg bid based on per subject tolerability intervention 2: up to 4 capsules bid as tolerated

intervention 1: pregabalin (Lyrica) intervention 2: placebo

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00646451

[ 0 ]

26

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore experimental.

null

Hodgkin's Disease Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma

RITUXIMAB Lymphoma

null

1

arm 1: Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.

[ 0 ]

1

[ 0 ]

intervention 1: Rituximab 375 mg/m\^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is \> 200 cells/ul or a maximum of 6 doses have been given.

intervention 1: Rituximab

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00648037

[ 4 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This pilot trial in Finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first visits on days 1, 2, 4 or 5 and 7 ± 1.

null

Schizophrenic Disorders

Schizophrenia Schizoaffective psychosis Schizophreniformic psychosis Pilot study Quetiapine Prolong Risperidone

null

2

arm 1: Oral arm 2: Oral

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Oral administration intervention 2: Oral administration

intervention 1: Quetiapine intervention 2: Risperidone

4

Harjavalta | N/A | Finland | 22.13333 | 61.31667 Helsinki | N/A | Finland | 24.93545 | 60.16952 Pitkäniemi | N/A | Finland | 23.57654 | 61.48226 Turku | N/A | Finland | 22.26869 | 60.45148

0

NCT00660595

[ 3 ]

29

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

null

28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).

28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30 U TI Inhalation Powder cartridge to a single subcutaneous injection of 10 IU of RAA will be compared.

Diabetes Mellitus: Type 1

Diabetic adult male, diabetic adult female

null

3

arm 1: Technosphere® Insulin Inhalation Powder, two 15 U cartridges arm 2: Technosphere® Insulin Inhalation Powder, one 30 U cartridge arm 3: Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: TI Inhalation Powder, two 15 U cartridges intervention 2: TI Inhalation Powder, one 30 U cartridge intervention 3: RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.

intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Technosphere Insulin® Inhalation Powder intervention 3: RAA Population

2

0

NCT00662857

[ 2 ]

20

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.

null

Hepatitis, Chronic Hepatitis C Virus

null

2

arm 1: None arm 2: Dose study drug in subjects who have previously failed to respond to interferon based therapies

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Study drug will be administered 700mg BID in the fed state for three days. intervention 2: Study drug will be given 450mg BID for a duration of 10 days.

intervention 1: Small Molecule Agent (PF-868554) intervention 2: Small Molecule Agent (PF-868554)

1

Gainesville | Florida | United States | -82.32483 | 29.65163

0

NCT00671671

[ 3 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.

The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks. Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2

Acne Vulgaris

null

2

arm 1: PDT using MAL crem arm 2: PDT using Placebo cream

[ 0, 2 ]

1

[ 0 ]

intervention 1: Cream application followed by illumination with red light

intervention 1: Methyl aminolevulinate (MAL) PDT

2

0

NCT00673933

[ 5 ]

53

RANDOMIZED

PARALLEL

9OTHER

4QUADRUPLE

false

0ALL

false

The main purposes of this study are to find out if the study drug losartan (Cozaar) or placebo ("sugar pill") has an effect on insulin sensitivity (how your body responds to insulin) and to measure the effect of the study drug losartan or placebo on how the arteries in your arm dilate (enlarge to carry more blood). We hope to learn if taking losartan changes the amount of certain proteins in the blood that effect blood vessel function. Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4 months for you to complete this study.

null

Obesity Hypertension Hyperglycemia

Impaired Fasting Glucose FPG >100-<126 mg/dL

null

2

arm 1: Losartan 100 mg 1 tab po QD arm 2: Placebo 1 tab po QD

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: losartan 100 mg tablets 1 tab po QD intervention 2: Placebo 1 po QD

intervention 1: losartan intervention 2: Placebo control

9

0

NCT00675987

[ 3 ]

33

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

false

2MALE

true

The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.

To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer. The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective. 1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with prostate cancer 1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with prostate cancer 1.3 Determine the effects of Polyphenon E on MAPK activation in patients with prostate cancer 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with prostate cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with prostate cancer 1.6 Determine the effects of Polyphenon E on serum Prostate Specific Antigen (PSA) in patients with prostate cancer 1.7 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3), Hepatocyte Growth Factor HGF 1.8 Evaluate the safety and tolerability of Polyphenon E in this subject population

Prostate Cancer

EGCG polyphenols biomarkers prostate specific antigen

null

1

arm 1: Single arm for a phase II study

[ 0 ]

1

[ 0 ]

intervention 1: 4 capsules daily with a meal for the duration of the study

intervention 1: Polyphenon E (EGCG)

1

Shreveport | Louisiana | United States | -93.75018 | 32.52515

0

NCT00676780

[ 5 ]

45

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

1FEMALE

false

The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.

null

Premenstrual Dysphoric Disorder Premenstrual Syndrome

hormones menses PMS PMDD

null

2

arm 1: PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months arm 2: None

[ 0, 4 ]

1

[ 0 ]

intervention 1: Fluoxetine 20 mg daily by mouth for 2-3 months.

intervention 1: fluoxetine

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00678574

[ 0 ]

21

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

1FEMALE

true

Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.

null

PCOS

null

2

arm 1: PCOS subjects given diazoxide arm 2: Normal subjects given diazoxide

[ 0, 1 ]

1

[ 0 ]

intervention 1: 100mg orally three times per day for 10 days

intervention 1: diazoxide

1

Richmond | Virginia | United States | -77.46026 | 37.55376

0

NCT00683774

[ 2 ]

19

RANDOMIZED

PARALLEL

9OTHER

1SINGLE

true

0ALL

false

The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects in 2 visits to determine the effect of topical nitroglycerin on radial artery vasodilation. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours.

During the first study visit, as a dose-optimizing study, each subject will be randomly assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. On the second study visit, the same participants will be randomly assigned to one of two Combination-Test arms to receive bilateral topical application of either 20mg or 40mg of lidocaine; the lidocaine will be applied in combination with 30mg of nitroglycerin on one wrist and in combination with placebo on the other wrist. Measurements of radial artery diameter will be performed as in the first visit.

Healthy

To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization

null

4

arm 1: Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1 arm 2: Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1 arm 3: Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2 arm 4: Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2

[ 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 15mg Nitroglycerin applied topically to one wrist intervention 2: 30mg Nitroglycerin applied topically to one wrist intervention 3: 20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo intervention 4: 40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo intervention 5: Topical skin moisturizing cream with same appearance as active agent

intervention 1: Nitroglycerin 15mg intervention 2: Nitroglycerin 30mg intervention 3: Lidocaine 20mg intervention 4: Lidocaine 40mg intervention 5: Placebo

1

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

0

NCT00686231

[ 4 ]

336

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

null

Psoriasis

Plaque-type Psoriasis Psoriasis

null

2

arm 1: U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. arm 2: Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). intervention 2: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

intervention 1: U0267 intervention 2: Vehicle

13

0

NCT00688519

[ 3 ]

118

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

null

Moderate to Severe COPD

COPD

null

2

arm 1: AZD1981 Oral tablet, twice daily arm 2: Placebo Oral tablet, twice daily

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Oral tablet, twice daily intervention 2: Placebo Oral tablet, twice daily

intervention 1: AZD1981 intervention 2: Placebo

21

Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Arhus C | N/A | Denmark | N/A | N/A Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Værløse | N/A | Denmark | 12.36856 | 55.78251 Krakow | N/A | Poland | 19.93658 | 50.06143 Lublin | N/A | Poland | 22.56667 | 51.25 Ostrów Wielkopolski | N/A | Poland | 17.80686 | 51.65501 Przemyśl | N/A | Poland | 22.76728 | 49.78498 Rzeszów | N/A | Poland | 21.99901 | 50.04132 Bojnice | N/A | Slovakia | 18.5864 | 48.78511 Liptovský Hrádok | N/A | Slovakia | 19.72335 | 49.03962 Poprad | N/A | Slovakia | 20.29798 | 49.06144 Spišská Nová Ves | N/A | Slovakia | 20.56153 | 48.94464 Žilina | N/A | Slovakia | 18.73941 | 49.22315 Lund | N/A | Sweden | 13.19321 | 55.70584 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Uppsala | N/A | Sweden | 17.63889 | 59.85882

0

NCT00690482

[ 4 ]

17

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

true

This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.

null

Cystic Fibrosis Pancreatic Exocrine Insufficiency

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 12,000 unit Capsules, dosed individually based on fat intake. intervention 2: Placebo

intervention 1: Pancrelipase Delayed Release intervention 2: Placebo Comparator

10

0

NCT00690820

[ 3 ]

184

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

1SINGLE

true

0ALL

false

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

null

Alzheimer's Disease Mild Cognitive Impairment

null

3

arm 1: None arm 2: MCI (mild cognitive impairment) arm 3: None

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: IV injection, 370MBq (10mCi), single dose

intervention 1: florbetapir F 18

15

0

NCT00702143

[ 3 ]

142

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depression in patients with Major Depressive Disorder. The safety and tolerability of the combination product will also be evaluated as measured by adverse events and vital signs.

Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.

Major Depressive Disorder

depression

null

3

arm 1: BCI-024: over-encapsulated Buspirone tablet 15 mg at bedtime(QD) and BCI-049: over-encapsulated Melatonin tablet 3 mg QD arm 2: BCI-024: over-encapsulated Buspirone 15 mg QD arm 3: Placebo: 1 capsule QD

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and Drug BCI-049: over-encapsulated Melatonin tablet 3 mg QD taken in combination for 6 weeks intervention 2: Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks. intervention 3: Placebo comparator once a day at bedtime for 6 weeks.

intervention 1: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD intervention 2: BCI-024 (Buspirone) intervention 3: Matching placebo

9

0

NCT00705003

[ 3 ]

87

null

PARALLEL

0TREATMENT

null

false

2MALE

null

The primary objective of this trial is to estimate and compare the 12-week progression-free rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in patients with HRPC as determined by radiographic, bone and PSA criteria.

null

Prostatic Neoplasms

null

0

null

3

[ 0, 0, 0 ]

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

intervention 1: BIBF 1120 intervention 2: BIBW 2992 intervention 3: Sequential BIBF 1120 + BIBW 2992

9

Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Bournemouth | N/A | United Kingdom | -1.8795 | 50.72048 Brighton | N/A | United Kingdom | -0.13947 | 50.82838 Cheltenham | N/A | United Kingdom | -2.07972 | 51.90006 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328 Southampton | N/A | United Kingdom | -1.40428 | 50.90395 Sutton | N/A | United Kingdom | -0.2 | 51.35 Truro | N/A | United Kingdom | -5.05436 | 50.26526

0

NCT00706628

[ 5 ]

16

RANDOMIZED

CROSSOVER

2DIAGNOSTIC

1SINGLE

true

0ALL

false

The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. In this case, the medication pregabalin will be used. The investigators hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.

Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, pregabalin. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Anxiety Disorders

anxiety functional magnetic resonance imaging fMRI pregabalin Lyrica

null

3

arm 1: Pregabalin oral tablets (50 mg) arm 2: Pregabalin oral tablets (200 mg) arm 3: Placebo

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan intervention 2: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan intervention 3: One dose of matched oral placebo to be administered one hour prior to fMRI scan

intervention 1: Pregabalin 50mg intervention 2: Pregabalin 200 MG intervention 3: placebo

1

La Jolla | California | United States | -117.2742 | 32.84727

0

NCT00706836

[ 0 ]

40

NON_RANDOMIZED

PARALLEL

null

0NONE

true

1FEMALE

false

There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women. Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (\>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.

null

Pharmacokinetics

contraceptive ring obesity pharmacokinetics pharmacodynamics Pharmacokinetics of the contraceptive ring in obese women.

null

2

arm 1: Obese subjects (BMI 30-39.9)received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use. arm 2: Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Obese subjects (BMI 30-39.9) will receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use. intervention 2: Normal weight subjects will also receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.

intervention 1: NuvaRing intervention 2: NuvaRing

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00710606

[ 5 ]

7

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

false

0ALL

false

The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from post-allergen peak)

The aim of this pilot study is to evaluate whether fluticasone propionate affects the late allergic reaction after a single dose post-allergen challenge administered following cessation of the early allergic reaction. Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of asthma will be and includes the presence of variable airflow limitation and AHR (PC20 methacholine \< 16 mg/mL). Subjects will be asked to participate if they demonstrate an allergen-induced early and late asthmatic response of at least 20% and 15% reduction in FEV1, respectively. The study will consist of 4 periods, composed of a screening allergen period with 3 subsequent allergen challenge/treatment periods. Each period will be separated with a washout of at least 2 weeks. Subjects who demonstrate a dual asthmatic response in the screening period will be selected for randomization to treatment.

Mild Intermittent Asthma

late allergic response fluticasone propionate

null

3

arm 1: Fluticasone propionate (Flovent Diskus) 250 mcg arm 2: budesonide 400mcg arm 3: placebo

[ 1, 1, 2 ]

3

[ 0, 0, 10 ]

intervention 1: Flovent Diskus 250 mcg intervention 2: budesonide 400 mcg intervention 3: Placebo

intervention 1: Fluticasone propionate (Flovent Diskus) 250 mcg intervention 2: budesonide 400 mcg intervention 3: Placebo

1

Hamilton | Ontario | Canada | -79.84963 | 43.25011

0

NCT00716963

[ 4 ]

259

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).

null

Controlled Ovarian Stimulation

Reproductive techniques assisted

null

2

arm 1: ganirelix arm 2: triptorelin

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration. intervention 2: a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 \<= 50 pg/ml (\<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.

intervention 1: ganirelix intervention 2: triptorelin

0

null

0

NCT00725491

[ 5 ]

261

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.

null

Perennial Allergic Rhinitis

null

3

arm 1: Pediatrics 3 to 6 years arm 2: Pediatrics 7 to 15 years arm 3: Adults 16 to 64 years

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks intervention 2: loratadine 10 mg tablet once daily for 4 weeks intervention 3: loratadine 10 mg tablet once daily for 4 weeks

intervention 1: loratadine intervention 2: loratadine intervention 3: loratadine

0

null

0

NCT00730912

[ 3 ]

37

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.

null

Asthma Airway Obstruction

Asthma airway obstruction beta2-agonist efficacy inhalation

null

6

arm 1: AZD3199 120 microgram arm 2: AZD3199 480 microgram arm 3: AZD3199 1920 microgram arm 4: Placebo arm 5: Formoterol 9 microgram arm 6: Formoterol 36 microgram

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

3

[ 0, 0, 0 ]

intervention 1: Dry powder for inhalation, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Dry powder for inhalation, single dose

intervention 1: AZD3199 intervention 2: Formoterol intervention 3: Placebo

4

Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Luleå | N/A | Sweden | 22.15465 | 65.58415 Lund | N/A | Sweden | 13.19321 | 55.70584

0

NCT00736489

[ 2 ]

68

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

null

Chronic Asthma

Chronic asthma

null

4

arm 1: montelukast Placebo arm 2: montelukast arm 3: montelukast arm 4: montelukast

[ 2, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo. intervention 2: 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.

intervention 1: Comparator: montelukast intervention 2: Comparator: placebo

0

null

0

NCT00739297

[ 3 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.

null

Sarcoidosis

null

1

arm 1: None

[ 5 ]

1

[ 0 ]

intervention 1: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.

intervention 1: Abatacept

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00739960

[ 4 ]

9

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.

This is a multinational study with sites in the US, India, Singapore, South Korea, Mexico and Chile. There will be 210 subjects (male or female) enrolled that are residing in community or facilities with a reliable caregiver that have been clinically diagnosed with Down syndrome. The assessments performed during this study will be used to evaluate skills. The study duration will be 10 weeks of double blind treatment with a total of 6 visits; 4 in office visit and 2 phone visits.

Down Syndrome Cognitive Dysfunction

pediatric Down syndrome cognitive dysfunction Downs Aricept children with Down syndrome

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: All subjects will start with a dose of 1.25 mg/day (1.25 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally. intervention 2: All subjects will start with a dose of 1.25 mg/day (1.25 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) placebo. All doses will be administered orally.

intervention 1: Aricept (Donepezil hydrochloride) intervention 2: Placebo

2

0

NCT00754013

[ 4 ]

8

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, aged 11 to 17.

The study will be conducted in approximately 75 sites in the US, India, Singapore, South Korea, Mexico and Chile and will include 210 participants to be enrolled.

Down Syndrome Cognitive Dysfunction

Pediatric Down syndrome Downs Cognitive Dysfunction of Down syndrome

null

3

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

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalation will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally. intervention 2: All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) donepezil. All doses will be administered orally. intervention 3: All participants will start with a dose of 2.5 mg/day (2.5 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) placebo. All doses will be administered orally.

intervention 1: Aricept (donepezil hydrochloride) intervention 2: Aricept (donepezil hydrochloride) intervention 3: Placebo

2

0

NCT00754052

[ 3 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis

This is a single center, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily for 12 weeks. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.

Psoriasis

Plaque Type Psoriasis Topical

null

2

arm 1: AN2728 Ointment, 5% arm 2: AN2728 Ointment vehicle

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: AN2728 Ointment, 5%, twice daily for 12 weeks intervention 2: Ointment vehicle, twice daily for 12 weeks

intervention 1: AN2728 intervention 2: Ointment vehicle

1

Mexico City | Mexico City | Mexico | -99.12766 | 19.42847

0

NCT00755196

[ 2 ]

25

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006

null

Type 2 Diabetes Mellitus

null

12

arm 1: Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5. arm 2: Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. arm 3: Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. arm 4: Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. arm 5: Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. arm 6: Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5 arm 7: Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. arm 8: Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. arm 9: Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. arm 10: Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. arm 11: Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5 arm 12: Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.

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

2

[ 0, 0 ]

intervention 1: MK1006 capsules: 1 mg, 10 mg, and 20 mg. Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose intervention 2: Placebo capsule to match MK1006 1, 10, and 20 mg. Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose

intervention 1: MK1006 intervention 2: Placebo

0

null

0

NCT00757601

[ 5 ]

500

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.

null

Pain

null

1

arm 1: Etoricoxib

[ 0 ]

1

[ 0 ]

intervention 1: etoricoxib 60 mg QD for 4 weeks.

intervention 1: etoricoxib

0

null

0

NCT00757627

[ 4 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

true

0ALL

true

Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.

null

Periodontitis

null

2

arm 1: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. arm 2: Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses. intervention 2: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

intervention 1: Triclosan/copolymer/fluoride intervention 2: Fluoride

0

null

0

NCT00762762

[ 4 ]

626

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

Hypersensitivity

null

Dentin Hypersensitivity

null

2

arm 1: sensitive toothpaste arm 2: Triclosan control toothpaste

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Brush twice daily intervention 2: Brush twice daily

intervention 1: Triclosan, Silicon dioxide, fluoride intervention 2: Triclosan, fluoride

1

Cedar Knolls | New Jersey | United States | -74.44876 | 40.82204

0

NCT00763269

[ 3 ]

45

RANDOMIZED

FACTORIAL

null

0NONE

true

0ALL

false

To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the entry inhibitor maraviroc. COL112237 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and maraviroc (MVC) pharmacokinetics in 48 healthy, HIV-negative adults after administration of a 7-day regimen of MVC 300mg BID alone and after 14-day regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/RTV 100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent MVC 300mg BID. Blood samples for drug concentration measurement will be collected over 12 hours at the end of each dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period.

This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for PK sampling and a follow-up visit. The screening visit will be conducted within 30 days prior to receiving the first dose. Subjects will then be randomized into 1 of 6 treatment groups as shown below: Cohort Size Period 1 Days 1 to 7 Period 2 Days 1-14 Period 3 Days 1-14 A 8 MVC 300mg BID; FPV 1400mg BID; FPV 1400mg BID \& MVC 300mg BID B 8 MVC 300mg BID; FPV 1400mg BID \& MVC 300mg BID; FPV 1400mg BID C 8 MVC 300mg BID; FPV 700mg BID \& RTV 100mg BID; FPV 700mg BID \& RTV 100mg BID \&MVC 300mg BID D 8 MVC 300mg BID; FPV 700mg BID \& RTV 100mg BID \& MVC 300mg BID; FPV 700mg BID \& RTV 100mg BID E 8 MVC 300mg BID; FPV 1400mg QD \& RTV 100mg QD; FPV 1400mg QD \& RTV 100mg QD \& MVC 300mg BID F 8 MVC 300mg BID; FPV 1400mg QD \& RTV 100mg QD \& MVC 300mg BID; FPV 1400mg QD \& RTV 100mg QD Study subjects will enter the clinic in the morning prior to dosing and remain at the center for 12 hours following each dose. Fourteen to 21 days following completion of the third dosing period, study subjects will return to the clinic for follow-up assessment. The total duration of the study will be approximately 86 days from screening through follow up. Blood samples for drug concentration measurement of amprenavir (APV) and maraviroc(MVC) concentrations will be collected over 12 hours at the end of each dosing period (at 0 \[baseline\], 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose). Subjects will undergo a physical examination, CBC with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests except those for HIV and hepatitis B/C will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period. Evaluable patients will be required to have adhered to at least 95% of their study drug doses. Plasma APV and MVC concentrations will be analyzed using a validated high-performance liquid chromatography method with tandem mass spectrometric detection (HPLC/MS/MS). Plasma APV and MVC pharmacokinetic parameters measured will include maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration (Cmin), and area under the concentration-time curve (AUC). All these parameters, except Tmax, will be log-transformed before statistical analysis. Analysis of variance, considering treatment as a fixed effect and subject as a random effect will be performed using Statistical Analysis Software (SAS), and assuming a treatment ratio for steady-state APV PK parameters as 1.0, the 90% confidence intervals will be within the range 0.81-1.24.

Healthy

Healthy Subjects Pharmacokinetics study Pharmacokinetics of medications

null

6

arm 1: Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID arm 2: Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID arm 3: Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID arm 4: Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID arm 5: Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID arm 6: Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD

[ 1, 1, 1, 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 300 mg BID intervention 2: 1400 mg BID, 700 mg BID or 1400 mg QD intervention 3: 100 mg BID, 100 mg QD

intervention 1: Maraviroc intervention 2: Fosamprenavir intervention 3: Ritonavir

1

Voorhees Township | New Jersey | United States | -74.49062 | 40.4795

0

NCT00764465

[ 3 ]

5

NA

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

0ALL

true

• To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)

• 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.

Acne Vulgaris

acne Botox cosmetic treatments

null

1

arm 1: Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)

[ 0 ]

2

[ 0, 0 ]

intervention 1: 1.5-3 units of Botox/lesion intervention 2: .1 cc bacteriostatic saline/lesion

intervention 1: Botulinum Neurotoxin Type A intervention 2: Bacteriostatic saline

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00765375

[ 2 ]

34

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

false

This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.

null

Familial Adenomatous Polyposis

Polyp, Familial Adenomatous Polyposis, Prevention

null

2

arm 1: 20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS arm 2: 20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 20 grams BRB Slurry intervention 2: Two, 730 mg BRB suppositories QHS intervention 3: 20 grams BRB placebo slurry

intervention 1: Black raspberry (BRB) Slurry intervention 2: Black Raspberry (BRB) Suppositories intervention 3: Black Raspberry (BRB) Placebo Slurry

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00770991

[ 5 ]

165

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

null

Attention-Deficit/Hyperactivity Disorder (ADHD)

ADHD, children, subjects, laboratory classroom

null

3

arm 1: Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days. arm 2: Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days. arm 3: Two Capsules taken orally once a day for 7 days

[ 0, 1, 2 ]

2

[ 0, 0 ]

intervention 1: 10 mg and/or 20 mg capsules intervention 2: Placebo Comparator

intervention 1: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) intervention 2: Placebo

8

0

NCT00776009

[ 0 ]

26

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine the response rate of the combination of bortezomib and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS).

In patients who develop acute myelogenous leukemia (AML) or a high-risk myelodysplastic syndrome (MDS), the current standard treatment involves multidrug induction chemotherapy utilizing an anthracycline or anthraquinone with cytarabine. While chemotherapy has proven effective at inducing remission in up to 90% of patients, elderly patients fair far worse. In patients over the age of sixty, the disease is not only less responsive to therapy, but an increased number of comorbid conditions makes induction therapy a more dangerous endeavor. Because of this, many patients are not offered standard induction chemotherapy and there is a dearth of viable alternatives for treatment of these otherwise fatal diseases. Low dose melphalan has previously been shown to be an effective palliative treatment for patients diagnosed with AML and high-risk MDS. It was found to have an overall response rate of 40% in AML patients (30% complete remission and 10% partial remission) and a 57% overall response in high-risk MDS patients (33% complete remission, 5% partial remission, and 19% minor responses). This therapy, while not curative, is one of the few options for patients unable to tolerate more intensive treatment regimens, but desiring a potentially effective palliative regimen. Bortezomib (VELCADE®) is an intravenously administered reversible, selective inhibitor of the 26S proteosome. Although all of the mechanisms by which this novel drug acts as an antineoplastic agent are not fully understood, in vivo and in vitro studies indicate they ultimately result in the inhibition of the gene expression necessary for cell growth and survival pathways, apoptotic pathways, and cellular adhesion, migration, and angiogenesis mechanisms. Preclinical and clinical evaluation of the combination of melphalan and bortezomib has demonstrated impressive synergy in refractory multiple myeloma cell lines and patients with myeloma. This study aims to determine if these findings hold true in AML and MDS patients.

Acute Myelogenous Leukemia Myelodysplastic Syndromes

Acute Myelogenous Leukemia AML Myelodysplastic Syndromes MDS Melphalan Bortezomib Velcade

null

1

arm 1: All patients will receive the following regimen: 1) Melphalan 2 mg orally, once daily. 2) Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Melphalan: 2mg orally, once daily intervention 2: Bortezomib: 1.0mg/M2 IV on days 1, 4, 8, 11 intervention 3: None

intervention 1: Melphalan intervention 2: Bortezomib intervention 3: Melphalan and bortezomib

2

0

NCT00789256

[ 3 ]

132

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

2DOUBLE

false

0ALL

false

The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children

null

Allergic Rhinitis

Allergic Rhinitis Pediatric PATANASE

null

2

arm 1: Olopatadine Hydrochloride Nasal Spray 0.6% arm 2: Olopatadine Hydrochloride Nasal Spray Vehicle

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: one spray in each nostril twice daily for 2 weeks intervention 2: one spray in each nostril twice daily for 2 weeks

intervention 1: Olopatadine Hydrochloride Nasal Spray 0.6% intervention 2: Olopatadine Hydrochloride Nasal Spray Vehicle

1

Waco | Texas | United States | -97.14667 | 31.54933

0

NCT00794144

[ 4 ]

2

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.

This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhone HCl compared to twice daily morphine SR, in Taiwan participants with cancer pain. The study consists of 3 phases: Screening phase (14 days before administration of study drug), Dose titration phase (3 to 14 days) and Dose maintenance phase (14 days). This study will include 8 visits (Visit 1 \[Day 1\], Visit 2 \[Day 1-13 telephonic\], Visit 3 \[Day 14\], Visit 4 \[Day 15 to Day 21 telephonic\], Visit 5 \[Day 22\], Visit 6 \[Day 23 to 27 telephonic\] and Visit 7 \[Day 28\]). In dose titration phase, participants will be randomly assigned to 1 of the 2 treatments, OROS hydromorphone or morphine SR and dose of study medication will be adjusted every 48 hours at Investigator's discretion according to participant's analgesic (drug used to control pain) requirements. Morphine HCl will be used as rescue medication (maintained at 3 doses per day or less) for breakthrough pain. Participants primarily will be evaluated for equivalence of efficacy using the "worst pain" item of the brief pain inventory (BPI). Participants' safety will be monitored throughout the study duration.

Cancer Pain

Pain Hydromorphone hydrochloride OROS Morphine

null

2

arm 1: Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase. arm 2: Participants will receive morphine SR 8 mg every 24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase. intervention 2: Participants will receive morphine SR 8 mg every24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.

intervention 1: Hydromprphone Hydrochloride (HCl) OROS intervention 2: Morphine Sustain Release (SR)

0

null

0

NCT00803283

[ 5 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.

null

Glaucoma, Open Angle Ocular Hypertension

null

6

arm 1: Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% arm 2: Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% arm 3: Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% arm 4: Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% arm 5: Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% arm 6: Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%

[ 1, 1, 1, 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 0.5% intervention 2: 0.5% intervention 3: 0.5%

intervention 1: Timolol Maleate in Sorbate intervention 2: Timolol hemihydrate intervention 3: Timolol maleate gel forming solution

2

0

NCT00804648

[ 5 ]

30

RANDOMIZED

CROSSOVER

null

1SINGLE

true

0ALL

false

The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

null

Normal Healthy Subject Population

null

2

arm 1: Zegerid® arm 2: Prilosec OTC®

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: capsule(20 mg omeprazole/sodium bicarbonate), single dose intervention 2: Omeprazole-magnesium 20.6 mg, tablet, single dose

intervention 1: Zegerid® intervention 2: Prilosec OTC®

1

Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756

0

NCT00808769

[ 5 ]

226

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

true

1FEMALE

false

This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.

There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.

Ovarian Suppression

Ovarian Suppression Oral Contraceptives Obese and Normal BMI

null

2

arm 1: Participants with a BMI of 19-24.9 kg/m\^2 arm 2: Participants with a BMI of 30-39.9 kg/m\^2

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet. intervention 2: Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.

intervention 1: Low dose formulation intervention 2: High dose formulation

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00827632

[ 2 ]

52

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

2MALE

false

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.

null

Healthy

Rotigotine Neupro® Transdermal Patch

null

2

arm 1: Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days arm 2: Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days

[ 0, 0 ]

1

[ 0 ]

intervention 1: Rotigotine 4.5mg/10cm\^2 patch applied for 24 hours

intervention 1: Rotigotine transdermal patch

1

Neuss | North Rhine-Westphalia | Germany | 6.68504 | 51.19807

0

NCT00881894

[ 3 ]

5

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.

null

T-cell Lymphoma

non cutaneous peripheral t-cell lymphoma with nodal involvement

null

2

arm 1: CHOP chemo therapy + CD4 therapy arm 2: CHOP chemotherapy

[ 0, 1 ]

2

[ 2, 0 ]

intervention 1: None intervention 2: None

intervention 1: CHOP + CD4 intervention 2: CHOP

0

null

0

NCT00893516

[ 4 ]

85

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will provide data on additional therapeutic benefits in administering Adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of treatment with etanercept.

A total of 50 patients with psoriasis vulgaris who showed an unsatisfactory response to etanercept 50 mg twice a week followed by 50 mg once a week and a total of 50 patients who showed an unsatisfactory response to etanercept 50 mg twice a week without dose reduction will be recruited. All patients will receive adalimumab 40 mg every other week (EOW) for 12 weeks. Patients who fail to reach a physician's global assessment (PGA) of clear or almost clear at week 12 will have an increase in adalimumab to 40 mg every week (EW) for an additional 12 weeks. Patients who reach a PGA of clear or almost clear at week 12 will continue to receive adalimumab at 40 mg EOW for an additional 12 weeks. Patients will be evaluated for safety and efficacy every 4 weeks for a total of 24 weeks. PASI, BSA and PGA will be performed at each visit. Routine chemistry, hematology and urinalysis will be performed every 4 weeks. The percentage of patients achieving a physician's global assessment (PGA) of clear or almost clear after at least 12 weeks of adalimumab will be calculated for patients who had shown an unsatisfactory response to 3 months of etanercept at 50 mg twice a week without dose reduction as well as for patients who had shown an unsatisfactory response to 3 months of etanercept at 50 mg twice a week followed by 50 mg once a week. A physician's global assessment (PGA) of clear is defined by no plaque elevation over normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. A physician's global assessment (PGA) of almost clear is defined as follows: It is possible but difficilt to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a definite red coloration.

Plaque Psoriasis

Adalimumab

null

4

arm 1: Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening. arm 2: Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening. arm 3: Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks. arm 4: Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.

[ 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Adalimumab 40mg injection every other week for 24 weeks intervention 2: Adalimumab 40mg injection every week for the last 12 weeks of study.

intervention 1: Adalimumab every other week intervention 2: Adalimumab Every Week

12

0

NCT00927069

[ 5 ]

24

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

2MALE

false

The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.

null

Bacterial Infection

Bioequivalence

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Tablet, 100 mg, Single dose intervention 2: Tablet, 100 mg, Single dose

intervention 1: doxycycline monohydrate tablet intervention 2: doxycycline carragenate tablet

1

Ahmedabad | Gujarat | India | 72.58727 | 23.02579

0

NCT00939562

[ 5 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Study Status: Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed. Enrollment Update: Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. With no recruitment interest, the financial sponsor and Sponsor-PI chose to close the clinical trial.

This is an open-label study using alefacept in the treatment of patients with chronic plaque psoriasis who have not responded to treatment with an anti-TNF agent. Patients not responding to Enbrel® 50 mg weekly with a 75% reduction of Psoriasis Area and Severity Index (PASI) Score or a Physician Global Assessment (PGA) score of 'almost clear' or 'clear', will be treated with 15 mg alefacept intramuscularly (IM) once weekly for up to 20 weeks. Patients who have 'cleared' or 'almost cleared' at the end of 12 weeks of treatment with alefacept will have completed the 'standard treatment' phase of the study. Study subjects who have not responded to treatment during the initial 12 weeks will continue with alefacept therapy for an additional 8 weekly doses or until the subject has reached a PGA of 'almost clear' or 'clear'. Alefacept is FDA approved for this indication for 12 weeks of treatment and this clinical trial is extending the treatment window for up to 8 additional weeks. Because of this increased exposure to alefacept, all subjects will be carefully monitored while on treatment and followed post-treatment at 3, 4, 6, 9 and 12 months after the last dose of alefacept is given. Purpose: This open-label study will determine the safety and efficacy of Amevive® 15 mg IM weekly in subjects with chronic plaque psoriasis who have not sufficiently responded to etanercept, an anti-TNF agent. The plan also is to determine the length of response time to point of relapse and to determine the length of time before retreatment with alefacept is necessary. Patient Population: This study is for adult men and women, ages 18 to 80, with chronic plaque psoriasis. At the time of enrollment, the subject must have received 50 mg per week of Enbrel without achieving a response of 'almost clear' or 'clear' according to PGA or has not responded with a 75% reduction of PASI Score.

Chronic Plaque Psoriasis

null

1

arm 1: Alefacept will be given to subjects with plaque psoriasis who have failed treatment with Fnbrel.

[ 0 ]

1

[ 0 ]

intervention 1: Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a response to anti-TNF therapy prior to entering this study.

intervention 1: alefacept

0

null

0

NCT00953329

[ 2 ]

26

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

true

2MALE

false

The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.

Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older men showed a correlation between loss of muscle cross-sectional area and muscle strength of the thigh, quadriceps, and flexor muscles. Once weakened, older individuals are prone to falls that prevent independent living and diminish the quality of life. There is a need to develop therapies to counteract losses in skeletal muscle strength with aging. Studies show that exercise and testosterone administration increase skeletal muscle mass and strength in older men. However, the increase in muscle strength by testosterone in older men has not been consistent in all studies. Androgens increase muscle mass by either increasing muscle protein synthesis or inhibiting muscle protein breakdown. This proposal will investigate the hypothesis that cyclic testosterone administration (monthly on/off cycles) will preferentially increase muscle protein synthesis and result in a consistent and greater improvement in muscle strength than continuous testosterone administration.

Hypogonadism

Low Normal Testosterone Male Aging

null

3

arm 1: Weekly placebo treatment for a duration of 5 months. arm 2: A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months. arm 3: Weekly testosterone treatment for a duration of 5 months

[ 2, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Weekly im injections of 100 mg testosterone enanthate. intervention 2: Weekly IM injections of sesame oil.

intervention 1: Testosterone intervention 2: Placebo

1

Galveston | Texas | United States | -94.7977 | 29.30135

0

NCT00957528

[ 0 ]

16

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session. This is a randomized three period cross-over study including treatment with Terbutaline, a 20% basal reduction for six hours, or no treatment (control).

In this study, a minimum of 16 youth with type 1 diabetes will be recruited. All subjects must have been diagnosed with type 1 diabetes for at least one year and on an insulin pump for at least one month. Subjects are between the ages of 10 and 17 years, inclusive, have an HbA1c less than 10.0% and normal thyroid function. Subjects can not have had a severe hypoglycemic episode in the last three months, any other illness or treatment that may affect the wearing of a continuous glucose monitor or the completion of the study as determined by the investigator. Subjects may not use drugs containing pseudoephedrine within 48 hours of the study visits. This study consists of three overnight visits at the Clinical Translational Research Center. Meals eaten during the study will be consistent for each of the three visits. Subjects will participate in a standardized afternoon exercise session on a treadmill as has been done in previous Diabetes Research in Children Network studies. Exercise will begin at 4pm and must be completed by 6pm. Dinner will be eaten at the end of the exercise. At 9pm, treatment will be given as determined by the randomization group the subject is assigned to. The treatment includes either an oral dose of 2.5mg Terbutaline, a 20% basal reduction for six hours or no treatment as the control. Blood glucose levels will be measured every 30 minutes until 6am.

Type 1 Diabetes

Children Exercise Hypoglycemia

null

3

arm 1: Subjects complete the same exercise routine, however no treatment is given at 9:00pm. arm 2: Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered. arm 3: All subjects complete the same exercise session. At 9:00pm, subject's basal rate is decreased by 20% for six hours.

[ 1, 0, 0 ]

3

[ 0, 10, 10 ]

intervention 1: Oral (2.5mg) one time administration at 9:00pm intervention 2: Basal insulin rate is reduced by 20% the normal (home dose) for six hours. intervention 3: No treatment is given for the study. This arm is for comparison with the two intervention arms.

intervention 1: Terbutaline intervention 2: 20% basal insulin reduction intervention 3: Control

1

Aurora | Colorado | United States | -104.83192 | 39.72943

0

NCT00974051

[ 4 ]

41

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.

null

Embolism, Pulmonary

Fondaparinux sodium contrast-enhanced MDCT Deep Vein Thrombosis Pulmonary thromboembolism

null

2

arm 1: None arm 2: None

[ 0, 5 ]

2

[ 0, 0 ]

intervention 1: The dose of Fondaparinux will be determined based on a subject's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection. intervention 2: UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.

intervention 1: Fondaparinux sodium intervention 2: unfractionated heparin (UFH)

27

Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Gunma | N/A | Japan | N/A | N/A Gunma | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ibaraki | N/A | Japan | 135.56828 | 34.81641 Ibaraki | N/A | Japan | 135.56828 | 34.81641 Kagoshima | N/A | Japan | 130.55 | 31.56667 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Mie | N/A | Japan | 131.58333 | 32.96667 Nagano | N/A | Japan | 138.18333 | 36.65 Nagasaki | N/A | Japan | 129.88333 | 32.75 Niigata | N/A | Japan | 139.04125 | 37.92259 Okayama | N/A | Japan | 133.93333 | 34.65 Osaka | N/A | Japan | 135.50107 | 34.69379 Osaka | N/A | Japan | 135.50107 | 34.69379 Osaka | N/A | Japan | 135.50107 | 34.69379 Saitama | N/A | Japan | 139.65657 | 35.90807 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00981409

[ 4 ]

54

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

2MALE

false

The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.

The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce coronary artery disease (CAD) events. Although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. The results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. In the present study, we will investigate whether statins can decrease visceral obesity in humans.

Abdominal Obesity

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 10 mg once daily intervention 2: once daily

intervention 1: Rosuvastatin intervention 2: Placebo for rosuvastatin

1

Gothenburg | N/A | Sweden | 11.96679 | 57.70716

0

NCT01068626

[ 3 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.

This was a Phase 2, parallel-group, active-control, randomized, double-blind study conducted to evaluate a single local administration of low dose or high dose of SKY0402 compared with 75 mg of bupivacaine HCl (i.e., Marcaine® 0.5%) in women undergoing bilateral, cosmetic, sub-muscular, augmentation mammoplasty under general anesthesia. Each subject was to serve as her own control. A total of 40 subjects were randomized in a 1:1 ratio to receive one of the following regimens: * Low-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side. * Mid-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side. Study drug was administered locally into the breast implant pocket at the end of surgery. After surgery, subjects were to receive standard treatment with acetaminophen 1000 mg three times daily and rescue analgesia with immediate-release oxycodone, as needed, for breakthrough pain. Assessments of postoperative pain were conducted through 96 hours. Safety assessments were conducted including monitoring of local and systemic adverse events (AEs).

Postoperative Pain

Breast augmentation Pain Analgesia

null

2

arm 1: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 arm 2: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket intervention 2: Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

intervention 1: SKY0402 + bupivacaine HCl intervention 2: Mid-dose SKY0402 + bupivacaine HCl

1

La Jolla | California | United States | -117.2742 | 32.84727

0

NCT01206608

[ 3 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

null

The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.

null

Primary Open Angle Glaucoma

null

2

arm 1: One drop. arm 2: One drop

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: One drop at 8.00pm. intervention 2: One drop at 8.00pm.

intervention 1: T2345 intervention 2: Prostaglandin

0

null

0

NCT01494753

[ 4 ]

188

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.

This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.

Schizophrenia

Schizophrenia Paliperidone ER Treatment naive patients Newly diagnosed patients

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.

intervention 1: Paliperidone ER

0

null

0

NCT01606228

[ 0 ]

140

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.

null

Kidney Stone

null

2

arm 1: ESWL with hydration and inversion arm 2: ESWL with hydration

[ 0, 1 ]

3

[ 3, 3, 0 ]

intervention 1: Patients inverted 30 degree head down in Trendelenburg position intervention 2: Shock wave lithotripsy intervention 3: Hydration of patient with 0.5L NaCl and 20mg frusemide IV

intervention 1: Inversion intervention 2: Shock Wave Lithotripsy intervention 3: Hydration

0

null

0

NCT01852669

[ 4 ]

160

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli).

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), comparative, parallel (a clinical trial comparing the response in 2 or more groups of participants receiving different treatments) double-arm, multi-center (when more than 1 hospital or medical school team work on a medical research study) study. The study consists of 3 phases: Screening phase on Visit 1 (Day -3/1); Inclusion or treatment phase on Visit 2 (Day 1); and Treatment or monitoring phase (3 days after treatment) on Visit 3 (Day 7 for Gynoclin V and Day 13 for Vagitrol V) and Visit 4 (Day 12 for Gynoclin V and Day 18 for Vagitrol V). Participants will be randomly assigned to 1 of the 2 treatment groups: Gynoclin V and Vagitrol V. Participants in Gynoclin V group will be administered 1 ovule (containing 80 milligram \[mg\] terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide) vaginally every 24 hours at night, for 3 days. Participants in the Vagitrol V group will be administered 1 ovule (containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin) vaginally every 24 hours at night, for 10 days. Primarily, participants will be evaluated for signs and symptoms, characteristics of vaginal discharge, changes in vulvar region, changes in cervix and presence of bacteria, fungi and/or parasites. Participants' safety will be monitored throughout the study.

Vaginitis Infectious Vaginosis

Vaginitis Infectious vaginosis Terconazole Clindamycin Fluocinolone Metronidazole Nystatin

null

2

arm 1: One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. arm 2: One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. intervention 2: One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.

intervention 1: Gynoclin V intervention 2: Vagitrol V

2

DF | Mexico City | Mexico | N/A | N/A Mexico City | N/A | Mexico | -99.12766 | 19.42847

0

NCT01867164

[ 3 ]

6

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study. This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Hyperkalemia

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 15 grams/day (5 grams 3 times daily) administered orally

intervention 1: patiromer

2

0

NCT02033317

[ 4 ]

16

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will compare the efficacy of CellCept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.

null

Lupus Nephritis

null

2

arm 1: Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m\^2), intravenously (IV) pulse once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), orally (PO); the dose was reduced by 5 mg/day to a final dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received mycophenolate mofetil (MMF), 1 g/day, PO, twice daily (BID) for 2 weeks; 1.5 g/day, PO, three times daily (TID) for the next 2 weeks; 2 g/day, PO, BID for the remainder of the Maintenance Phase. Participants also received prednisone, as in the Induction Phase. arm 2: Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 - 1 g/m\^2, IV, pulse once per month. Participants also received prednisone, 1 mg/kg/day), PO; the dose was reduced by 5 mg/day to a final dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m\^2, IV, pulse once every 3 months. Participants also received prednisone, as in the Induction Phase.

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase. intervention 2: 0.5-1 g/m\^2 IV pulse once every 3 months intervention 3: 0.5 - 1 g/m\^2 IV pulse once per month intervention 4: 1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

intervention 1: Mycophenolate mofetil (MMF) intervention 2: Cyclophosphamide, Maintenance Phase intervention 3: Cyclophosphamide, Induction Phase intervention 4: Prednisone

2

Barquisimeto | N/A | Venezuela | -69.35703 | 10.0647 Caracas | N/A | Venezuela | -66.87919 | 10.48801

0

NCT02081183

[ 2 ]

16

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

2MALE

false

To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)

Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least 14 days. On each treatment period, after completion of pre-dose assessments, BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® 100/25; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose. Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.

Parkinson's Disease (PD)

Parkinson's disease (PD) Opicapone BIA 9-1067

null

4

arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25 arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25 arm 3: Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25 arm 4: Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

[ 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: Immediate-release levodopa/carbidopa 100/25 mg

intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Sinemet® 100/25

1

Mount Royal | Quebec | Canada | -73.64918 | 45.51675

0

NCT02169479

[ 2 ]

17

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.

null

Non-Small Cell Lung Cancer

Non-Squamous

null

2

arm 1: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 100 mg orally (PO). arm 2: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 150 mg orally (PO).

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Erlotinib will be administered as oral tablets. intervention 2: Pertuzumab will be administered as intravenous (IV) infusion.

intervention 1: Erlotinib intervention 2: Pertuzumab

3

Antwerp | N/A | Belgium | 4.40026 | 51.22047 Barcelona | N/A | Spain | 2.15899 | 41.38879 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT02507375

[ 4 ]

31

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.

null

Hepatitis D, Chronic

null

1

arm 1: Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.

[ 0 ]

1

[ 0 ]

intervention 1: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.

intervention 1: Pegylated Interferon (PEG-IFN) alfa-2a

7

Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Constanța | N/A | Romania | 28.63432 | 44.18073 Craiova | N/A | Romania | 23.8 | 44.31667 Iași | N/A | Romania | 27.6 | 47.16667 Timișoara | N/A | Romania | 21.22571 | 45.75372

0

NCT02732639

[ 2 ]

48

RANDOMIZED

SEQUENTIAL

0TREATMENT

2DOUBLE

true

0ALL

false

The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.

null

Postmenopausal Osteopenia

null

2

arm 1: Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months. arm 2: Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, or 3 mg/kg Q4W for 3 months.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

intervention 1: Romosozumab intervention 2: Placebo

0

null

0

NCT01825785

[ 3 ]

54

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.

This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in participants with major depressive disorder. In Part I of the trial, four different cohorts of six participants each will receive multiple rising doses of MK-8777 (ranging from 100 mg twice a day \[BID\] to 300 mg BID) or placebo for up to 16 days. In Part 2, a new cohort of participants will be randomly assigned to receive 100 mg BID of MK-8777, 400 mg BID of MK-8777, or placebo. Following titration (3 days per step), participants will be maintained on the assigned BID dose until Day 27, followed by one day of once a day (QD) dosing, for a total of 28 days. There were 11 treatment arms in total for Part 1 and Part 2 (see Interventions).

Depression

randomized placebo controlled maximum tolerated dose

null

11

arm 1: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. arm 2: Participants receive placebo BID for a total of 16 days. arm 3: Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. arm 4: Participants receive placebo BID for a total of 13 days. arm 5: Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. arm 6: Participants receive placebo BID for a total of 10 days. arm 7: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. arm 8: Participants receive placebo BID for a total of 13 days. arm 9: Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. arm 10: Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. arm 11: Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.

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

2

[ 0, 0 ]

intervention 1: Orally administered capsules containing either 50 mg or 100 mg MK-8777. intervention 2: Orally administered matching placebo capsules.

intervention 1: MK-8777 intervention 2: Placebo

0

null

0

NCT00610649

[ 3 ]

5

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by subthreshold emotional arousing (or symptom stimulating) tasks will be determined using functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation between the change in rCBF and the efficacy. The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12 weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after the last dose, for a total of 18-21 weeks. Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.

null

Post-Traumatic Stress Disorder Stress Disorders, Post-Traumatic

PTSD (Posttraumatic Stress Disorder) CAPS fMRI Paroxetine

null

2

arm 1: Drug 2 (20 mg/day or placebo) will be administered once daily after supper for the first two weeks after the run-in phase. If the investigator/subinvestigator judges that a sufficient response is achieved, Drug 2 will be continued for the remaining period. If a sufficient response is not achieved with Drug 2 but treatment is well tolerated, the dose will be titrated to one step higher level until a sufficient response is achieved \[i.e., Drug 3 (30 mg/day or placebo) → Drug 4 (40 mg/day or placebo) → Drug 5 (50 m/day or placebo)\] at intervals of at least two weeks by once daily administration after supper. Once a sufficient response is achieved, that dose will be continued. arm 2: placebo

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) intervention 2: placebo

intervention 1: paroxetine intervention 2: placebo

9

Chiba | N/A | Japan | 140.11667 | 35.6 Chiba | N/A | Japan | 140.11667 | 35.6 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00557622

[ 2 ]

17

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.

This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or metformin. Part 2 (to be conducted in India): this part of the study will be conducted after completion of Part 1 and an analysis indicates a clinically significant decrease in blood glucose in participants with type 2 diabetes mellitus (T2DM) compared to placebo. The same procedures conducted in Part 1 will be conducted in Part 2.

Type 2 Diabetes Mellitus

null

6

arm 1: Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks. arm 2: Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks. arm 3: Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks. arm 4: Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks. arm 5: Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks. arm 6: Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.

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

3

[ 0, 0, 0 ]

intervention 1: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks intervention 2: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks intervention 3: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

intervention 1: SCH 497079 intervention 2: Placebo intervention 3: Metformin

0

null

0

NCT00673465

[ 3 ]

117

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.

Down Syndrome

null

1

arm 1: All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant's weight schedule and the Investigator's judgment of safety and tolerability. Re-titration was done to maintain the blinding of the double-blind study (E2020-A001-219). Doses could be decreased due to tolerability and could be increased or decreased to maintain a maximum dose of 0.1 to 0.2 mg/kg/day based on the participant's weight at clinic visits during the study duration.

[ 0 ]

1

[ 0 ]

intervention 1: Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.

intervention 1: Donepezil hydrochloride (Aricept)

31

0

NCT00675025

[ 3 ]

10

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this research study is to look at concentrations of GSK189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. The clinical effects of the drug in combination with insulin on the body will also be studied. The results will help determine doses of GSK189075 can be studied in the future in the type I diabetes mellitus population.

null

Diabetes Mellitus, Type 1

type 1 Diabetes mellitus, pharmacokinetics, pharmacodynamics Adult male and females,

null

2

arm 1: GSK189075 arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: investigational drug intervention 2: placebo comparator

intervention 1: GSK189075 intervention 2: placebo

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00575159

[ 4 ]

142

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting

This study has both an optimization and double-blind period

ADHD

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting intervention 2: Placebo administered once-daily for one week during the adult workplace environment setting

intervention 1: LDX intervention 2: Placebo

5

0

NCT00697515

[ 4 ]

301

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

null

Atrophy Vaginal Diseases

Menopausal symptoms Vulvar and vaginal atrophy in menopausal women Vaginal atrophy Urogenital atrophy

null

1

arm 1: Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Ospemifene 60Mg Oral Tablet

0

null

1

NCT01586364

[ 3 ]

576

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.

null

Pulmonary Disease, Chronic Obstructive

COPD Multicenter GSK233705B double-blind Chronic Obstructive Pulmonary Disease (COPD) randomized

null

6

arm 1: GSK233705 12.5mcg arm 2: GSK233705 25mcg arm 3: GSK233705 50mcg arm 4: GSK233705 100mcg arm 5: GSK233705 200mcg arm 6: Placebo

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

6

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

intervention 1: Once daily via dry powder inhaler intervention 2: once daily via dry powder inhaler intervention 3: Once daily via dry powder inhaler intervention 4: Once daily via dry powder inhaler intervention 5: Once daily via dry powder inhaler intervention 6: Once daily via dry powder imhaler

intervention 1: GSK233705 12.5mcg intervention 2: GSK233705 25mcg intervention 3: GSK233705 50mcg intervention 4: GSK233705 100mcg intervention 5: GSK233705 200mcg intervention 6: Placebo

88

0

NCT00676052

[ 3 ]

27

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.

Hysterectomy is the second most common surgery among women in the United States (US). Abdominal hysterectomy surgery may be performed to treat benign tumors, such as fibroids, heavy periods, painful periods and chronic pelvic pain. The most common route for performing hysterectomy is through an incision in the abdominal wall; however, about 20% are performed vaginally.Laparoscopic assisted vaginal hysterectomy is performed when warranted. Bupivacaine is a local anesthetic (pain medication) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cattle tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery. The ON Q system consists of 1 elastometric pump with a fill volume of 270 mL containing 0.25% bupivacaine; 1 soaker catheter measuring 12.5 cm in size; and a fill port, tubing, clamp, filter and flow restrictor. The pump provides positive pressure and is portable. It may be attached to the patient's dressing or placed in a carrying pouch. The catheter is inserted directly into the surgical wound providing a continuous flow of bupivacaine into the wound. A capillary flow restricting orifice located at the end of the tubing controls the flow rate. This study will compare the total narcotic use in patients with the CollaRx Bupivacaine Implant with the total narcotic use in patients with the ON Q PainBuster Post op Pain Relief System after abdominal hysterectomy.

Pain, Postoperative

Abdominal Hysterectomy Postoperative pain

null

2

arm 1: Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line. arm 2: Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride intervention 2: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])

intervention 1: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) intervention 2: ON-Q PainBuster Post-op Pain relief System

1

Boynton Beach | Florida | United States | -80.06643 | 26.52535

0

NCT00749749

[ 3 ]

564

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

1FEMALE

true

This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.

null

Osteoporosis

bone mineral density, Ronacaleret teriparatide alendronate, Post-menopausal women, osteoporosis, SB-751689

null

4

arm 1: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 2: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 3: Open-label arm. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 4: 4 arms, 100mg, 200mg, 300mg, 400mg. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study.

[ 4, 1, 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 100mg, 200mg, 300mg, 400mg intervention 2: PTH (1-34) intervention 3: Bisphosphonate

intervention 1: Ronacaleret intervention 2: Teriparatide intervention 3: Alendronate

49

Oakland | California | United States | -122.2708 | 37.80437 Palm Desert | California | United States | -116.37697 | 33.72255 Walnut Creek | California | United States | -122.06496 | 37.90631 Decatur | Georgia | United States | -84.29631 | 33.77483 Bethesda | Maryland | United States | -77.10026 | 38.98067 Akron | Ohio | United States | -81.51901 | 41.08144 Cleveland | Ohio | United States | -81.69541 | 41.4995 Portland | Oregon | United States | -122.67621 | 45.52345 Duncansville | Pennsylvania | United States | -78.4339 | 40.42341 Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | N/A | N/A Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 St Leonards | New South Wales | Australia | 151.19836 | -33.82344 Footscray | Victoria | Australia | 144.9 | -37.8 Geelong | Victoria | Australia | 144.36069 | -38.14711 Heidelberg | Victoria | Australia | 145.06667 | -37.75 Ghent | N/A | Belgium | 3.71667 | 51.05 Liège | N/A | Belgium | 5.56749 | 50.63373 Tienen | N/A | Belgium | 4.9378 | 50.80745 Ballerup Municipality | N/A | Denmark | 12.36328 | 55.73165 Frankfurt am Main | Hesse | Germany | 8.68417 | 50.11552 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Shatin | N/A | Hong Kong | 114.18333 | 22.38333 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Bergen | N/A | Norway | 5.32415 | 60.39299 Hamar | N/A | Norway | 11.06798 | 60.7945 Oslo | N/A | Norway | 10.74609 | 59.91273 Grudziądz | N/A | Poland | 18.75366 | 53.48411 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Panorama | N/A | South Africa | 31.89113 | -28.75383 Rosebank | N/A | South Africa | 18.47417 | -33.95556 Somerset West | N/A | South Africa | 18.82113 | -34.08401 Seoul | N/A | South Korea | 126.9784 | 37.566 Suwon | N/A | South Korea | 127.00889 | 37.29111 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052

0

NCT00471237

[ 3 ]

69

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

true

To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance, ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients

Efficacy Measures: Endurance, Ambulation, Cognitive function, Insulin resistance, Cholesterol and triglycerides, Muscle function and strength, Pain, Gastrointestinal function, Quality of life MINIMUM INCLUSION CRITERIA 1. A diagnosis of DM1, confirmed by DM1 genetic mutation 2. Age 21 to 65 years (inclusive) 3. Ability to walk 30 feet - assistance with cane and/or leg bracing permitted 4. Able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication

Myotonic Dystrophy Type 1

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit. intervention 2: 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.

intervention 1: rhIGF-I/rhIGFBP-3 intervention 2: placebo

12

0

NCT00577577

[ 3 ]

76

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT).

This is a pilot study which began with a plan to enroll 50 patients (20 related and 30 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with Pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT). Patients with persistent or progressive malignancy after transplantation will be treated with GM-CSF (cytokine therapy) to assess its toxicity and potential therapeutic efficacy. Patients with persistent or progressive disease who fail or do not qualify for the cytokine therapy portion of the study will become candidates for donor leukocyte infusions. The purpose of this protocol remains a pilot study which is now regarded as a phase II trial with a plan to enroll 40 ADDITIONAL patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a modified version of the original preparative regimen of Pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT). Patients who fail will become candidates for donor-leukocyte infusion (DLI). Primary Objectives 1. To determine the safety of treating hematological malignancies by establishing donor hematopoietic chimerism using pentostatin and low-dose total body irradiation followed by allogeneic peripheral blood stem cell transplantation. 2. To determine the immunomodulatory effects of pentostatin as part of the conditioning regimen for allogeneic peripheral blood stem cell transplantation. Secondary Objectives 1. To determine the incidence of infections after using a minimally myelosuppressive conditioning regimen. 2. To determine the kinetics of hematological and immunological reconstitution after allotransplantation with a minimally myelosuppressive conditioning regimen. 3. To determine the incidence of chronic GVHD after using allogeneic peripheral blood stem cell transplantation with a minimally myelosuppressive preparative regimen. 4. To evaluate the role of the preparative regimen and donor source (related versus unrelated) on inflammatory cytokine profiles. 5. To evaluate blood and where possible, biopsy specimens for a recently identified nuclear protein (molecular weight 44/46) in mononuclear cells obtained from study subjects. Interventions, evaluation, and follow up will include: Pentostatin 4 mg/m\^2/d intravenously once a day x 3 days will be administered with 1000 cc NS hydration before and after pentostatin ten days prior to stem cell infusion (days -10, -9, and -8). Total-body irradiation (TBI): TBI 2.0 Gy will be given on day -1. Antiemetics will be given as needed. Patients will receive one liter normal saline over 2 hours pre TBI. A bone marrow biopsy and aspiration with cytogenetics and flow cytometry will be performed on Day +28, Day +70 and 6, 12, 18 and 24 months following the transplant to monitor hematologic recovery. DNA fingerprinting will also be conducted at the same time at 3, 4, 5, 6, 12, 18, and 24 months to determine chimerism.

Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplastic Syndromes Multiple Myeloma Non-Hodgkins Lymphoma Hodgkins Disease Peripheral T-cell Lymphoma

null

1

arm 1: Pentostatin to be administered intravenously on days - 10, -9, and -8 at a dose of 4mg/m2/day

[ 0 ]

5

[ 0, 4, 0, 0, 0 ]

intervention 1: 4 mg/m\^2 intravenous(IV)once a day(QD)x3days (days -10, -9, -8) intervention 2: TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. TBI will be given on day -1. intervention 3: CsA will be given at 2.0 mg/kg intravenous (IV) Q 12hrs on days -1,0,and+1 (total 6 doses) then converted to oral at 2 mg/kg by mouth (PO) twice a day (BID) until day+80, then tapered 10% per week over approximately 3 months if no GVHD for related donor transplants. For unrelated CsA will be given at same dose and schedule until day+100 then tapered by 10% per week if no GVHD intervention 4: MMF 15 mg/kg by mouth twice a day (PO BID) will be given from day 0-27 then stopped without tapering for related donor transplants. For unrelated donor transplants MMF will be given at same dose until day+40 then tapered over 2months. in absence of GVHD. Doses will be rounded to nearest 250 mg. intervention 5: 10 mcg/kg/day subcutaneously for at least 4 consecutive days.

intervention 1: Pentostatin intervention 2: Total-body irradiation (TBI) intervention 3: Cyclosporine A (CsA) intervention 4: Mycophenolate Mofetil (MMF) intervention 5: G-CSF

1

Omaha | Nebraska | United States | -95.94043 | 41.25626

0

NCT00571662

[ 3 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.

Burns Sedation

pediatric burn sedation

null

1

arm 1: Ascending doses of dexmedetomidine (as per protocol)

[ 0 ]

1

[ 0 ]

intervention 1: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine \[in ug/kg/hr\], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.

intervention 1: Dexmedetomidine

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00697788

[ 5 ]

199

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.

null

Alzheimer's Disease

Alzheimer's disease

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.

intervention 1: Donepezil

15

Bundang | N/A | South Korea | N/A | N/A Changwon | N/A | South Korea | 128.68111 | 35.22806 Chuncheon | N/A | South Korea | 127.73417 | 37.87472 Chungju | N/A | South Korea | 127.9287 | 36.97666 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daejeon | N/A | South Korea | 127.38493 | 36.34913 Gyeonggi-do | N/A | South Korea | 126.76917 | 37.58944 Gyeonggi-do | N/A | South Korea | 126.76917 | 37.58944 Jeju City | N/A | South Korea | 126.52194 | 33.50972 Jeonju | N/A | South Korea | 127.14889 | 35.82194 Jinju | N/A | South Korea | 128.08472 | 35.19278 Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00381381

[ 4 ]

602

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

1FEMALE

false

This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.

null

Breast Neoplasms Osteoporosis

cancer-treatment related bone loss postmenopausal women breast cancer hormone receptor positive breast cancer adjuvant therapy hormonal therapy bone loss bisphosphonates ZFAST Letrozole Zoledronic Acid US32

null

2

arm 1: Participants in the upfront arm received zoledronate 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily. arm 2: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronate 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants received Zoledronate 4 mg IV 15-minute infusion every 6 months. intervention 2: Participants received Letrozole 2.5 mg daily.

intervention 1: Zoledronic Acid intervention 2: Letrozole

44

1

NCT00050011

[ 4 ]

577

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.

null

Diabetic Nephropathy Type 2 Diabetes Mellitus Proteinuria

angiotensin II type I receptor blockers diabetic nephropathy end-stage renal disease renal failure type 2 diabetes olmesartan medoxomil

null

2

arm 1: Olmesartan medoxomil tablets 10mg to 40 mg arm 2: Matching placebo tablets

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Tablets 10, 20, or 40 mg intervention 2: Matching placebo tablets

intervention 1: olmesartan medoxomil intervention 2: Placebo Tablets

2

Hong Kong | N/A | China | 114.17469 | 22.27832 Tokyo | N/A | Japan | 139.69171 | 35.6895

1

NCT00141453

[ 3 ]

172

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.

null

Carcinoma, Non-Small-Cell Lung Lung Neoplasms

Lung Cancer HKI-272 Neratinib Nerlynx

null

3

arm 1: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening arm 2: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening arm 3: HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, \< or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

intervention 1: HKI-272

19

1

NCT00266877

[ 5 ]

355

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to compare the effectiveness of two antipsychotic medications, RisperdalÂ® ConstaÂ® versus AbilifyÂ®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.

Although many patients with schizophrenia currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations of antipsychotics may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. The purpose of this trial is to evaluate the long-term effectiveness of Risperdal® Consta®, a long-acting injectable antipsychotic medication, versus Abilify®, an oral antipsychotic medication in patients with schizophrenia. The study will include patients, who in the investigator's opinion may benefit from a change in their current antipsychotic medication due to insufficient effectiveness, side effects or difficulty in adhering to a daily dose regimen. This is an open-label, randomized study in which patients will have an equal chance of receiving treatment for up to 2 years with Risperdal® Consta®, administered in the muscles near the hip every 2 weeks, or Abilify®, taken orally once daily. The initial dose and subsequent dose of study drug will be determined by the investigator. The patient's current oral antipsychotic medication will be decreased over the first four weeks of the study and discontinued. During the study, investigators may adjust the dose of study drug or add new antipsychotic medications to treat worsening psychotic symptoms. Patients may continue on or have added, antidepressants, mood stabilizers (except carbamazepine), sedative hypnotics, or anxiolytic medications during the study. Patients will return to the doctor's office every two weeks to receive an injection of Risperdal® Consta® or another supply of Abilify®. During certain visits, patients will be asked questions which will help the investigator determine the severity of the patient's illness, how well the study drug is working, quality of life, reasoning, memory, judgement and perception and side effects that may be associated with schizophrenia or treatment. Safety evaluations include the incidence of adverse events during the study, vital signs and clinical laboratory tests (both blood and urine). The study hypothesis is that Risperdal® Consta® is superior to Abilify® in the long-term treatment of subjects with schizophrenia as measured by time to relapse and time in remission. Treatment with Risperdal® Consta® (administered in the muscle every 2 weeks) at a dose of 25, 37.5 or 50 mg or Abilify® (administered orally daily) at a dose of 10-30 mg for 2 years. Investigators will determine the starting dose and may adjust the dosage of study drug during the study according to symptoms and treatment response.

Schizophrenia Psychotic Disorders

Schizophrenia Relapse Remission Treatment Outcome long-acting injectable

null

2

arm 1: None arm 2: None

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: 10-30 mg once daily for 104 weeks intervention 2: 25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks

intervention 1: Abilify intervention 2: Risperidal Consta

0

null

1

NCT00299702

[ 4 ]

3,221

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

null

Deep Vein Thrombosis Pulmonary Embolism

Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery

null

2

arm 1: Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. arm 2: Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 40 mg, administered once daily by subcutaneous injection, for 12 days intervention 2: 2.5 mg, administered twice daily as tablets, for 12 days intervention 3: Administered once daily by subcutaneous injection intervention 4: Oral tablet administered twice daily

intervention 1: Enoxaparin intervention 2: Apixaban intervention 3: Enoxaparin-matching placebo intervention 4: Apixaban-matching placebo

122

Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Linz | N/A | Austria | 14.28611 | 48.30639 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Belo Horizonte - Mg | Minas Gerais | Brazil | N/A | N/A São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 Santiago | Santiago Metropolitan | Chile | -70.64827 | -33.45694 Santiago | Santiago Metropolitan | Chile | -70.64827 | -33.45694 Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Qingdao | Shandong | China | 120.38042 | 36.06488 Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222 Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222 Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Medellín | N/A | Colombia | -75.57151 | 6.245 Santiago de Cali | N/A | Colombia | -76.5199 | 3.43054 Brno | N/A | Czechia | 16.60796 | 49.19522 Chomutov | N/A | Czechia | 13.41779 | 50.46048 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Uherské Hradiště | N/A | Czechia | 17.45969 | 49.06975 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Kolding | N/A | Denmark | 9.47216 | 55.4904 Viborg | N/A | Denmark | 9.40201 | 56.45319 Monaco | N/A | France | N/A | N/A Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Saint-Saulve | N/A | France | 3.55612 | 50.37141 Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925 Bochum | N/A | Germany | 7.21648 | 51.48165 Brandenburg | N/A | Germany | 12.55 | 52.41667 Dresden | N/A | Germany | 13.73832 | 51.05089 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Halle/S | N/A | Germany | N/A | N/A Kremmen Ot Sommerfeld | N/A | Germany | N/A | N/A Rheinfelden | N/A | Germany | 7.78715 | 47.56013 Witten | N/A | Germany | 7.35258 | 51.44362 Szeged | N/A | Hungary | 20.14824 | 46.253 Szekszárd | N/A | Hungary | 18.70905 | 46.35014 Ahmedabad | Gujarat | India | 72.58727 | 23.02579 Ludhiana | Punjab | India | 75.85379 | 30.91204 Bangalore | N/A | India | 77.59369 | 12.97194 Baroda | N/A | India | 76.65 | 25.5 Mangalore | N/A | India | 74.85603 | 12.91723 Jeruselem | N/A | Israel | N/A | N/A Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Safed | N/A | Israel | 35.496 | 32.96465 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096 Abano Terme (Pd) | N/A | Italy | 11.78725 | 45.35753 Bologna | N/A | Italy | 11.33875 | 44.49381 Pordenone | N/A | Italy | 12.66051 | 45.95689 Roma | N/A | Italy | 11.10642 | 44.99364 San Donato Milanese (Mi) | N/A | Italy | 9.26838 | 45.41047 Kuala Lumpur | Kuala Lumpur | Malaysia | 101.68653 | 3.1412 Kuala Lumpur | Kuala Lumpur | Malaysia | 101.68653 | 3.1412 Aguascalientes | Aguascalientes | Mexico | -102.2843 | 21.88262 Zapopan | Jalisco | Mexico | -103.38742 | 20.72111 San Luis Potosí City | San Luis Potosí | Mexico | -100.97135 | 22.15234 Hermosillo | Sonora | Mexico | -110.96677 | 29.08874 Veracruz | Veracruz | Mexico | -96.1429 | 19.18095 Ålesund | N/A | Norway | 6.15492 | 62.47225 Gjettum | N/A | Norway | 10.52911 | 59.90607 Kongsvinger | N/A | Norway | 11.99772 | 60.19049 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 Bytom | N/A | Poland | 18.93282 | 50.34802 Gdansk | N/A | Poland | 18.64912 | 54.35227 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Chelyabinsk | N/A | Russia | 61.42915 | 55.15402 Kazan' | N/A | Russia | 49.12214 | 55.78874 Lipetsk | N/A | Russia | 39.57076 | 52.60311 Moscow | N/A | Russia | 37.61556 | 55.75222 Rostov-on-Don | N/A | Russia | 39.72328 | 47.23135 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Samara | N/A | Russia | 50.15 | 53.20007 Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Randburg | Free State | South Africa | N/A | N/A Johannesburg | Gauteng | South Africa | 28.04363 | -26.20227 Johannesburg | Gauteng | South Africa | 28.04363 | -26.20227 Pretoria | Gauteng | South Africa | 28.18783 | -25.74486 Somerset West | Western Cape | South Africa | 18.82113 | -34.08401 Tygerberg | Western Cape | South Africa | N/A | N/A Worcester | Western Cape | South Africa | 19.44852 | -33.64651 Jeonnam | N/A | South Korea | N/A | N/A Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Badalona-Barcelona | N/A | Spain | N/A | N/A Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Valencia | N/A | Spain | -0.37966 | 39.47391 Borås | N/A | Sweden | 12.9401 | 57.72101 Cherkassy | N/A | Ukraine | 32.05738 | 49.44452 Chernivtsy | N/A | Ukraine | N/A | N/A Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664 Ivano-Frankivsk | N/A | Ukraine | 24.71248 | 48.92312 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Sevastopol | N/A | Ukraine | 33.52134 | 44.60795 London | Greater London | United Kingdom | -0.12574 | 51.50853 Epsom | Surrey | United Kingdom | -0.27011 | 51.3305

1

NCT00452530

[ 4 ]

903

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.

This is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. Patients will be randomly (allocation to treatments available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups. The three treatment groups are: Group 1 - CNTO 1275 45 mg dosing at weeks 0 and 4, Group 2 - CNTO 1275 90 mg dosing at weeks 0 and 4, Group 3 - Etanercept 50 mg two times per week through week 12. The total duration for each participant will be up to 64 weeks (approximately 16 months). The active-controlled portion of the study is from Week 0 to Week 12 during which the efficacy and safety of etanercept and 2 dose levels of CNTO 1275 will be evaluated. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. Patients will receive 2 subcutaneous injections of CNTO 1275 (either 45 or 90 mg doses) or twice weekly injections of etanercept during the first twelve weeks of the study. Patients may receive two additional doses of CNTO 1275 (either 45 or 90 mg doses) up to week 44.

Psoriasis

Psoriasis CNTO 1275 Etanercept Immune diorder Skin disorder

null

3

arm 1: Patients will receive CNTO 1275 45 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. arm 2: Patients will receive CNTO 1275 90 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment. arm 3: Patients will receive Etanercept 50 mg twice weekly through Week 12. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment.

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous intervention 2: Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous intervention 3: Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous

intervention 1: CNTO 1275 45 mg intervention 2: CNTO 1275 90 mg intervention 3: Etanercept 50 mg

0

null

0

NCT00454584

[ 4 ]

452

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.

This is a randomized (assigned by chance), open-label (all people know the identity of the intervention), active-controlled, parallel-group (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter (when more than one hospital or medical school team work on a medical research study) comparative study in participants with schizophrenia. This study comprises a screening period of not more than 7 days and a 13-week open-label treatment period. Paliperidone palmitate will be administered as intramuscular injection (injection of a substance into a muscle) of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. at Day 8, flexible dose on Day 36 (50 or 100 mg eq.) and on Day 64 (50, 100 or 150 mg eq.) depending on investigator's discretion. Risperidone LAI will be administered at a dose of 25 mg at Day 8 and Day 22, flexible dose on Day 36 (25 or 37.5 mg) and Day 64 (25, 37.5, or 50 mg). Dose on Day 50 is the same as Day 36 and dose on Day 78 is the same as Day 64. Participants will receive oral risperidone tablets (1 to 6 mg/day) for the first 4 weeks of the open-label treatment period. Each participant may receive oral risperidone tablets (1 to 2 mg daily) for up to 3 weeks at Day 36 and Day 64 if the dose of risperidone LAI was increased on Day 36 and Day 64. Efficacy will primarily be assessed using the Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be assessed.

Schizophrenia

Schizophrenia Paliperidone Paliperidone palmitate Risperidone Risperidone long acting injection R092670

null

2

arm 1: Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. arm 2: Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. intervention 2: Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

intervention 1: Paliperidone palmitate (R092670) intervention 2: Risperidone

8

Baoding | N/A | China | 115.46246 | 38.87288 Beijing | N/A | China | 116.39723 | 39.9075 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 Wuhan | N/A | China | 114.26667 | 30.58333 Xi'an | N/A | China | 108.92861 | 34.25833

1

NCT00604279

[ 3 ]

22

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens or ketoconazole) for metastatic, androgen-independent prostate cancer.

null

Prostate Cancer

null

1

arm 1: Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.

[ 0 ]

1

[ 0 ]

intervention 1: Ruxolitinib 25 mg tablets taken with water twice a day.

intervention 1: Ruxolitinib

15

1

NCT00638378

[ 4 ]

305

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Same as above.

Psoriasis

null

1

arm 1: clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

[ 1 ]

2

[ 0, 0 ]

intervention 1: clobetasol propionate spray, 0.05%, applied topically twice daily intervention 2: calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

intervention 1: clobetasol propionate spray 0.05% intervention 2: calcitriol ointment

12

1

NCT00658788

[ 4 ]

588

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.

null

Postoperative Dental Pain

null

5

arm 1: etoricoxib 90 mg arm 2: etoricoxib 120 mg arm 3: ibuprofen 2400 mg arm 4: acetaminophen 2400 mg/codeine 240 mg arm 5: Matching Placebo

[ 0, 0, 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: etoricoxib 90 mg; 120 mg (once daily) over three days. intervention 2: ibuprofen 2400 mg (600 mg Q6h) over three Days intervention 3: acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days intervention 4: matching placebo over three Days

intervention 1: Comparator: etoricoxib intervention 2: Comparator: ibuprofen intervention 3: Comparator: acetaminophen + codeine intervention 4: Comparator: placebo

0

null

1

NCT00694369

[ 4 ]

237

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating the pain and other symptoms associated with diabetic peripheral neuropathy.

null

Diabetic Neuropathy, Painful

Diabetic Peripheral Neuropathy

null

1

arm 1: Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.

[ 5 ]

1

[ 0 ]

intervention 1: None

intervention 1: Desvenlafaxine Succinate Sustained-Release (DVS SR)

0

null

1

NCT01050218