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

[ 2 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.

OBJECTIVES: Primary * To determine the maximum tolerated dose and toxicity of PEG-interferon alfa-2b and sorafenib tosylate in patients with unresectable or metastatic clear cell renal cell carcinoma. Secondary * To determine the progression-free survival of patients treated with this regimen. * To evaluate, in a preliminary manner, the response rate and overall survival of patients treated with this regimen. * To evaluate the activation of interferon-induced transcription factors in immune cell subsets (including regulatory T cells \[T regs\]) using a novel flow cytometric assay and correlate this information with clinical outcome. * To measure circulating levels of IFN-γ and IL-5 for determination of Th1/Th2 status and CD4+, CD25+, and FoxP3 cell number (T regs) in peripheral blood. OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, 15, 22, 29, 36, 43, and 50. Patients also receive oral sorafenib tosylate 2-3 times daily on days 15-56 of course 1 and on days 1-56 of all subsequent courses. Courses repeat every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and periodically during study for correlative laboratory studies. Peripheral blood mononuclear cells are analyzed for STAT proteins (STAT1, STAT2, STAT3, STAT4, STAT5) and CD4+, CD25+, and FoxP3 regulatory T cells by flow cytometric assays. Samples are also analyzed for the presence of VEGF, VEGFR, IFN-γ, and IL-5 by ELISA assays; baseline expression of Jak-STAT signaling intermediates (Jak1, Tyk2, IFNAR, and IRF9) by immunoblot analysis; and interferon-stimulated gene expression by real time PCR and RT-PCR analysis. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Kidney Cancer

clear cell renal cell carcinoma stage III renal cell cancer stage IV renal cell cancer

null

1

arm 1: Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

[ 0 ]

8

[ 2, 0, 6, 6, 6, 10, 10, 10 ]

intervention 1: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks. intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

intervention 1: PEG-interferon alfa-2b intervention 2: Sorafenib intervention 3: gene expression analysis intervention 4: polymerase chain reaction intervention 5: reverse transcriptase-polymerase chain reaction intervention 6: flow cytometry intervention 7: immunoenzyme technique intervention 8: laboratory biomarker analysis

1

Columbus | Ohio | United States | -82.99879 | 39.96118

0

NCT00589550

[ 5 ]

31

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Montelukast is a once daily LRA indicated for the treatment of allergic rhinitis and asthma, which is both safe and effective. Documented improvement in nasal congestion has been showed in patients with both seasonal and perennial allergic rhinitis. As demonstrated in recent publications, we fully anticipate that nasal congestion will be reduced in individuals afflicted with AR treated with montelukast. We have previously documented that a decrease in nasal congestion is associated with improved subjective sleep quality and subjective improvement in daytime somnolence. However, we have not demonstrated a cause and effect relationship. Currently, we have a study being performed that will allow us to assess the effect of nasal steroids on objective sleep by collecting data using a traditional overnight sleep test in subjects with congestion. We have not yet determined if subjective instruments for daytime somnolence correlate with objective measurements of improved daytime sleepiness. The purpose of this protocol will be three fold. First, we hope to determine the effectiveness of montelukast to reduce fatigue, somnolence and improve sleep, by reducing nasal congestion in allergic rhinitis. Two, we will assess the statistical relation between subjective instruments for sleepiness. Lastly, we want to determine the most appropriate test to use to determine daytime sleepiness or somnolence in patients with seasonal allergen induced congestion and daytime sleepiness. We will be dosing montelukast once a day, which is the manufacturer's suggested dosing schedule. Active drug will be compared to a placebo vehicle, which will mimic the active drug. With the proposed design study, a run-in period is not essential; however, to establish baseline symptoms and adherence to therapy, we have chosen a 1-week run-in while on placebo. After run-in, patients will be randomized to either active drug or placebo after baseline questionnaires and other data are collected. A daily diary to determine symptoms of allergic rhinitis and nighttime disturbance, as well as, daytime fatigue will be issued and expected to be completed daily. Two weeks after randomization, a follow-up will be scheduled in order to insure compliance, to collect diaries, administer questionnaires, and start the second treatment phase. After this visit study subjects will enter a 1-week wash-out and have a return visit before being randomized to the alternative arm. At six weeks, subjects will again be seen to insure compliance and administer questionnaires. The study will conclude following six-weeks. The data used for analyses will be the data collected during the last week of each randomized period. This will decrease cross over affect, typically seen in classical cross over studies, since there will be only a short washout between cross over. Subjects selected for this study will have a history of allergic rhinitis and a positive RAST or skin test to a perennial (year round) allergen and have symptoms that correlate with this allergen. If prior skin test or RAST is not available, a skin test will be performed to confirm allergic rhinitis. The patients will be seen in either the Allergy, Asthma, and Respiratory research center or the GCRC. All care and all studies will be done free of charge at no cost to the subject. Each subject will be compensated for his or her participation as outlined below. Patients will also be expected to have fatigue, daytime somnolence and poor sleep on study entry. An instrument to access the degree of fatigue, sleepiness and sleep quality will not only be required to be positive, but also must designate the symptom as greater than 50% on a severity rating.

Perennial Allergic Rhinitis

sleep somnolence allergies rhinitis fatigue

null

2

arm 1: montelukast 10 mg daily arm 2: Placebo tablet

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 10 mg po each day (compared to placebo for 2 weeks) intervention 2: placebo for 2 weeks

intervention 1: montelukast intervention 2: placebo

0

null

0

NCT00590772

[ 4 ]

100

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight

To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.

Pain Fever

null

1

arm 1: 40 to 75 mg/kg/day every 4 to 6 hours

[ 0 ]

1

[ 0 ]

intervention 1: Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose

intervention 1: IV Acetaminophen

14

0

NCT00598702

[ 2 ]

31

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

true

0ALL

false

Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo.

The Phase 1 clinical study compared the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo in 14 subjects with a history of sedative abuse. Subjects who met the inclusion/exclusion criteria received 2 mg of oral alprazolam and matching placebo over 2 sessions. Those who demonstrated greater liking for alprazolam versus placebo were eligible to participate in the study.

Abuse Liability of Staccato Alprazolam

null

14

arm 1: Sequence 1: Q, 1, 2, 7, 3, 6, 4, 5; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 2: Sequence Q, 2: 2, 3, 1, 4, 7, 5, 6; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 3: Sequence 3: Q, 3, 4, 2, 5, 1, 6, 7; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 4: Sequence 4: Q, 4, 5, 3, 6, 2, 7, 1; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 5: Sequence 5: Q, 5, 6, 4, 7, 3, 1, 2; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 6: Sequence 6: Q, 6, 7, 5, 1, 4, 2, 3; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 7: Sequence 7: Q, 7, 1, 6, 2, 5, 3, 4; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 8: Sequence 8: Q, 5, 4, 6, 3, 7, 2, 1; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 9: Sequence 9: Q, 6, 5, 7, 4, 1, 3, 2; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 10: Sequence 10: Q, 7, 6, 1, 5, 2, 4, 3; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 11: Sequence 11: Q, 1, 7, 2, 6, 3, 5, 4; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 12: Sequence 12: Q, 2, 1, 3, 7, 4, 6, 5; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 11=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 13: Sequence 13: Q, 3, 2, 4, 1, 5, 7, 6; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 14: Sequence 14: Q, 4, 3, 5, 2, 6, 1, 7; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 11=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg

[ 5, 5, 5, 5, 5, 5, 5, 5, 5, 5, 5, 5, 5, 5 ]

9

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

intervention 1: Inhaled Staccato placebo + oral placebo intervention 2: Inhaled Staccato alprazolam 0.5 mg + oral placebo intervention 3: Inhaled Staccato alprazolam 1 mg + oral placebo intervention 4: Inhaled Staccato alprazolam 2 mg + oral placebo intervention 5: Oral alprazolam 1 mg + Inhaled placebo intervention 6: Oral alprazolam 2 mg + Inhaled placebo intervention 7: Oral alprazolam 4 mg + Inhaled placebo intervention 8: Qualifying session (2 mg oral alprazolam) intervention 9: Qualifying control session (oral placebo)

intervention 1: Inhaled placebo + oral placebo intervention 2: Inhaled alprazolam 0.5 mg intervention 3: Inhaled alprazolam 1 mg intervention 4: Inhaled alprazolam 2 mg intervention 5: Oral alprazolam 1 mg intervention 6: Oral alprazolam 2 mg intervention 7: Oral alprazolam 4 m intervention 8: Oral alprazolam 2 mg qualifying session intervention 9: Oral placebo qualifying session

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00603980

[ 0 ]

18

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

2DOUBLE

false

0ALL

true

This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose or skin.

Omalizumab is a monoclonal antibody directed against Immunoglobulin E (IgE) and is FDA-approved for use in allergic asthma, though its clinical role is not precisely defined. It binds IgE on the same site of the Fc domain as the high affinity IgE receptor (FcεRI), and therefore, blocks the interaction between IgE and mast cells or basophils. It, therefore, may be used as a mechanistic tool in the study of IgE. As IgE levels are reduced with omalizumab, FcεRI expression on human basophils is reduced. This reduction of basophil receptors and allergen induced activation is pronounced within 7 days of the initial administration and is reversible once omalizumab administration is discontinued. The omalizumab-induced reductions in mast cell FcεRI expression and function is unchanged at day 7 and significantly reduced by day 70. These changes were based upon intravenously administered omalizumab at a dose of 0.03 mg/kg/IU IgE/mL in a total of three subjects. We propose to exploit the kinetics of faster omalizumab effects on circulating basophils relative to tissue mast cells to elucidate the role of the basophil versus mast cell activation in nasal airway allergen challenge, which has not been studied to date.

Allergic Rhinitis

Basophils Mast Cells IgE IgE receptors omalizumab

null

2

arm 1: This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks arm 2: This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dosing is based on IgE level and weight given every 2 or 4 weeks intervention 2: Dosing is based on IgE level and weight given every 2 or 4 weeks

intervention 1: omalizumab intervention 2: placebo

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00604786

[ 5 ]

10

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day for 14 days given in the other arm. The study is a randomized, open-label cross-over trial. There is at least a 3-week wash-out between the arms. The hypothesis is that the combination of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the change in the plasma level of potassium between the arms.

null

Hypokalemia

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 7 ]

intervention 1: Hydrochlorothiazide 25 mg a day for 14 days. intervention 2: Licorice candy 32 grams a day for 14 days.

intervention 1: Hydrochlorothiazide intervention 2: Licorice

1

Oulu | N/A | Finland | 25.46816 | 65.01236

0

NCT00605202

[ 0 ]

2

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

null

Treatment Induced Hypertension

null

2

arm 1: Minoxidil arm 2: Hydralazine

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week intervention 2: 25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week

intervention 1: Minoxidil intervention 2: Hydralazine

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00607477

[ 5 ]

17

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function.

null

Major Depressive Disorder

cognitive function psychosocial function augmentation treatment refractory depression

null

1

arm 1: This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.

[ 5 ]

1

[ 0 ]

intervention 1: varied dose (5, 10, 15 mg qd) for 6 wks

intervention 1: Aripiprazole

1

Dallas | Texas | United States | -96.80667 | 32.78306

0

NCT00608543

[ 5 ]

156

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.

null

Non Small Cell Lung Carcinoma

Carcinoma Non Small Cell Lung EGFR mutation Gefitinib

null

0

null

1

[ 0 ]

intervention 1: Gefitinib tablet 250mg once daily orally

intervention 1: Gefitinib

1

Daegu | N/A | South Korea | 128.59111 | 35.87028

0

NCT00608868

[ 4 ]

90

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.

null

Chronic Obstructive Pulmonary Disease

indacaterol chronic obstructive pulmonary disease exercise endurance moderate to severe chronic obstructive pulmonary disease COPD

null

2

arm 1: Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

intervention 1: Indacaterol 300 μg intervention 2: Placebo

20

Torrance | California | United States | -118.34063 | 33.83585 Lebanon | New Hampshire | United States | -72.25176 | 43.64229 Brussels | N/A | Belgium | 4.34878 | 50.85045 Gembloux | N/A | Belgium | 4.69889 | 50.56149 Jette | N/A | Belgium | 4.33419 | 50.87309 Liège | N/A | Belgium | 5.56749 | 50.63373 Edmonton | N/A | Canada | -113.46871 | 53.55014 Kingston | N/A | Canada | -76.48098 | 44.22976 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Odense | N/A | Denmark | 10.38831 | 55.39594 Genova | N/A | Italy | 11.87211 | 45.21604 Pisa | N/A | Italy | 10.4036 | 43.70853 Verona | N/A | Italy | 10.9938 | 45.43854 Alicante | N/A | Spain | -0.48149 | 38.34517 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Seville | N/A | Spain | -5.97317 | 37.38283 Zaragoza | N/A | Spain | -0.87734 | 41.65606

0

NCT00620022

[ 5 ]

228

NA

SINGLE_GROUP

0TREATMENT

0NONE

null

0ALL

null

This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm\^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting

null

Alzheimer's Disease

Alzheimer's disease cholinesterase inhibitor rivastigmine

null

0

null

1

[ 0 ]

intervention 1: The study treatment was delivered as a patch sizes 5 and 10 cm\^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm\^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm\^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm\^2.

intervention 1: Rivastigmine transdermal patch

1

Rueil-Malmaison | N/A | France | 2.18967 | 48.8765

0

NCT00622713

[ 5 ]

12

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

true

0ALL

true

The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.

There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.

Hypertension

Salt sensitivity of Blood Pressure

null

4

arm 1: Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). arm 2: Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). arm 3: Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). arm 4: Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).

[ 0, 0, 2, 2 ]

2

[ 0, 10 ]

intervention 1: Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet intervention 2: Placebo pill taken twice per day on each day of the diet

intervention 1: celecoxib (Celebrex) intervention 2: Placebo

1

Newark | Delaware | United States | -75.74966 | 39.68372

0

NCT00624559

[ 5 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair

null

Asthma

Asthma allergen challenge bronchoprovocation Methacholine challenge serum Immunoglobulin E Nitric Oxide skin prick test

null

4

arm 1: Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. arm 2: Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. arm 3: Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. arm 4: By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.

[ 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection; intervention 2: Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.

intervention 1: Xolair intervention 2: Placebo

6

Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Munich | N/A | Germany | 11.57549 | 48.13743 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Durban | N/A | South Africa | 31.0292 | -29.8579

0

NCT00624832

[ 4 ]

441

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

null

Diabetes Diabetes Mellitus, Type 2

null

2

arm 1: Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin arm 2: Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner intervention 2: Tablets, 500 - 2000 mg, once, twice or three times daily intervention 3: Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch

intervention 1: biphasic insulin aspart 30 intervention 2: metformin intervention 3: biphasic insulin aspart 50

1

Beijing | Beijing Municipality | China | 116.39723 | 39.9075

0

NCT00627445

[ 3 ]

324

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

null

Type 2 Diabetes

insulin resistance

null

4

arm 1: Teneligliptin 10 mg, orally, once daily arm 2: Teneligliptin 20 mg, orally, once daily arm 3: Teneligliptin 40 mg, orally, once daily arm 4: Teneligliptin placebo-matching tablets, orally, once daily

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

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

intervention 1: Teneligliptin 10mg intervention 2: Teneligliptin 20 mg intervention 3: Teneligliptin 40 mg intervention 4: Placebo

1

Takikawa-shi | Hokkaido | Japan | N/A | N/A

0

NCT00628212

[ 3 ]

262

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants.

null

Diabetes Mellitus Type 2

null

4

arm 1: LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks arm 2: LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks arm 3: LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks arm 4: Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks

[ 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: LY2189265 intervention 2: Placebo

34

0

NCT00630825

[ 3 ]

146

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

null

Diabetes Mellitus, Type 2

null

3

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

[ 0, 0, 1 ]

6

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

intervention 1: Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks). intervention 2: Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). intervention 3: Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks). intervention 4: Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period. intervention 5: Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). intervention 6: Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).

intervention 1: MK-0893 intervention 2: Sitagliptin intervention 3: Metformin intervention 4: Placebo for MK-0893 intervention 5: Placebo for Sitagliptin intervention 6: Placebo for Metformin

0

null

0

NCT00631488

[ 4 ]

362

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

null

Erectile Dysfunction

null

2

arm 1: Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. arm 2: Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT) intervention 2: Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

intervention 1: Vardenafil ODT (STAXYN, BAY38-9456) intervention 2: Placebo

47

0

NCT00631969

[ 3 ]

35

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. Various assays of platelet function will be used in this study. Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12, Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein (VASP), and Thromboelastography (TEG)-platelet mapping.

null

Diabetes Mellitus Coronary Artery Disease

null

2

arm 1: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. arm 2: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose. intervention 2: Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.

intervention 1: prasugrel intervention 2: Clopidogrel

4

0

NCT00642174

[ 3 ]

451

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.

Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).

Diabetes Mellitus, Type II Diabetes Mellitus, Non Insulin Dependent

Type 2 diabetes mellitus Metformin Hemoglobin A1c

null

7

arm 1: Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). arm 2: Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). arm 3: Each patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). arm 4: Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening). arm 5: Each patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks. arm 6: Each patient will receive 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). arm 7: Each patient will receive matching placebo twice daily for 12 weeks.

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

3

[ 0, 0, 0 ]

intervention 1: One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks. intervention 2: One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks. intervention 3: One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.

intervention 1: Canagliflozin (JNJ-28431754) intervention 2: Sitagliptin intervention 3: Placebo

78

0

NCT00642278

[ 0 ]

37

RANDOMIZED

CROSSOVER

null

0NONE

false

0ALL

false

The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge.

During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature) will be measured and they will perform standard spirometry. If the results of this test are 70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and urine will be collected for routine laboratory tests (CBC and routine urinalysis). If they are a female, a pregnancy test will be performed. During the second visit, subjects will inhale 1 or 2 doses of formoterol, (Foradil Aerolizer 12 mcg/capsule) a long-acting bronchodilator and 1 hour later, perform a methacholine test. At the end of the methacholine test, they will be given albuterol to reverse the effects of methacholine. On the third study day, they will repeat the second visit but with the opposite dose of Foradil.

Asthma

formoterol methacholine challenge

null

2

arm 1: a single dose of 24 mcg of formoterol arm 2: a single dose of 12 mcg of formoterol

[ 1, 1 ]

3

[ 0, 0, 1 ]

intervention 1: a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler) intervention 2: a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler) intervention 3: subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose

intervention 1: formoterol intervention 2: formoterol intervention 3: Dry Powder Inhaler (Twisthaler)

1

Gainesville | Florida | United States | -82.32483 | 29.65163

0

NCT00643578

[ 3 ]

55

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.

The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will be titrated up from 3.4g/day of Zerenex™ to maximum tolerated and safe doses of Zerenex™. Doses will be adjusted weekly, based on serum phosphorus levels, with the maximum dose administered being approximately 12g/day.

Hyperphosphatemia End-stage Renal Disease

ESRD end-stage renal disease end stage renal disease hemodialysis dialysis kidney failure renal failure kidney renal phosphate binder phosphorus

null

1

arm 1: All patients will be switched from their current phosphate binder to Zerenex, and titrated to the maximum tolerated dose (up to about 12g/day) based on their serum phosphorus levels.

[ 0 ]

1

[ 0 ]

intervention 1: ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.

intervention 1: ferric citrate

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00648167

[ 3 ]

85

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well as reducing the severity and frequency of symptoms of orthostatic hypotension in these patients. The efficacy of droxidopa in ameliorating symptoms in patients undergoing dialysis has also been demonstrated in the literature and clinical trials conducted in Japan. The current study will investigate the clinical efficacy of two different doses of droxidopa in patients with intradialytic hypotension over a 4 week treatment period with a placebo control. The clinical efficacy will be evaluated by changes in hypotension- related symptoms, as well as changes in blood pressure prior to, during and following, HD sessions as compared to their pre-treatment baseline values.

This is a phase II, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of droxidopa in HD patients with intradialytic hypotension. The study will be conducted in up to 15 centers, with a sufficient number of patients enrolled to allow 75 patients to be randomized into 3 study groups (25 randomized to placebo, 25 randomized to 400 mg droxidopa, and 25 randomized to 600 mg droxidopa). The study will consist of an initial screening period (up to 7 days) to confirm eligibility followed by a 2 week baseline, and a 4 week treatment period. During baseline and treatment visits SBP and DBP measurements will be collected using a consistent method immediately pre-, during and immediately post-dialysis. SBP, DBP and heart rate measurements will be taken every 20 minutes during HD sessions. There will be 19 scheduled visits, not including the post-treatment follow-up visit, during this trial; Visit 1 (Screening), Visits 2 through 7 (baseline and randomization), Visits 8 through 19 (tri-weekly treatment visits). Each visit will coincide with the patient's normal dialysis treatments. All patients will be followed for 30 days following the completion of the active treatment period (or premature withdrawal) to check for the occurrence of adverse events (AEs). Patients will attend the study center as out-patients. Eligible patients will be assigned a unique identification number at screening, and prior to the first treatment visit will be randomized to one of the following treatment groups: Group A: Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) Group B: Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) Group C: Placebo (3 capsules with mannitol substituted for droxidopa) Each patient will take 3 capsules 1 hour prior to each dialysis procedure with approximately 100 mL (typically half a glass) of water. The primary measure of efficacy will be the change from baseline (visits 2-7) in average mean arterial blood pressure compared to that during treatment (visit 14-19). The secondary measures of efficacy will be: * Change between baseline (visits 2-7) and treatment (visits 14-19) in average mean nadir systolic and diastolic blood pressures during hemodialysis; * Change in the number of hypotension-induced interventions during hemodialysis (HD) sessions; * Change in hypotension-induced symptoms measured during hemodialysis; * Change in daily symptoms associated with hemodialysis; * Change in fatigue using the Multidimensional Fatigue Inventory (MFI-20). The safety of droxidopa will be evaluated based on the occurrence of treatment-emergent adverse events (AE) and specific evaluation of blood pressure, heart rate (HR), ECG, and laboratory findings across the study.

Intradialytic Hypotension

null

3

arm 1: Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with Placebo) arm 2: Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) arm 3: Placebo (3 capsules with mannitol substituted for droxidopa)

[ 1, 1, 2 ]

2

[ 0, 0 ]

intervention 1: Capsules containing 200 mg droxidopa intervention 2: Capsules with mannitol substituted for droxidopa

intervention 1: Droxidopa intervention 2: Placebo

1

Medford | Oregon | United States | -122.87559 | 42.32652

0

NCT00657046

[ 4 ]

10

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. Bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.

Multiple Myeloma

null

2

arm 1: Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months arm 2: monitor myeloma parameters every 3-6 months

[ 1, 4 ]

1

[ 0 ]

intervention 1: Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks

intervention 1: Bortezomib

1

Little Rock | Arkansas | United States | -92.28959 | 34.74648

0

NCT00657553

[ 4 ]

614

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee.

3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.

Osteoarthritis

null

3

arm 1: PN400: 500 mg naproxen/20 mg esomeprazole arm 2: Celecoxib 200 mg arm 3: sugar pill

[ 0, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 500 mg naproxen/20 mg esomeprazole bid intervention 2: 200 mg celecoxib qd intervention 3: sugar pill bid intervention 4: Antacid Tablets

intervention 1: PN 400 (VIMOVO) intervention 2: celebrex intervention 3: Placebo intervention 4: Rescue Antacid

1

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

0

NCT00664560

[ 4 ]

610

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.

3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.

Osteoarthritis

null

3

arm 1: PN400: 500 mg naproxen/20 mg esomeprazole bid arm 2: Celecoxib 200 mg arm 3: sugar pill

[ 0, 1, 2 ]

4

[ 0, 0, 10, 0 ]

intervention 1: 500 mg naproxen/20 mg esomeprazole bid intervention 2: 200 mg celecoxib qd intervention 3: sugar pill bid intervention 4: Antacid Tablets

intervention 1: PN 400 (VIMOVO) intervention 2: celebrex intervention 3: Placebo intervention 4: Rescue Antacid

1

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

0

NCT00665431

[ 5 ]

728

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

null

Hypertension

Hypertension adults Valsartan + Amlodipine Angiotensin Receptor Blockers

null

2

arm 1: Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) arm 2: Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: valsartan and amlodipine intervention 2: valsartan and amlodipine

1

Metairie | Louisiana | United States | -90.15285 | 29.98409

0

NCT00666536

[ 0 ]

25

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

0NONE

true

0ALL

true

The purpose of this study is to determine the function of an enzyme that breaks down drugs and helps the removal of drugs from your body. This enzyme is called cytochrome P450 2C19 and is located in your liver. Exposure to other medications or variations in genes that you have inherited from your parents, may speed up or slow the function of this enzyme. As a result, some patients may develop unwanted effects from a drug while some other patients may not get benefit from taking the same drug. The aim of this study is to determine the function of this enzyme in your liver. We will do this by performing a series of breath tests and blood samples after you take pantoprazole. Pantoprazole is approved as an oral and intravenous drug by the Food and Drug Administration (FDA).

The goal of this study is to develop a quick and reliable method that will diagnose hepatic CYP2C19 function and could be used routinely in clinical practice. Specifically, we propose to test pantoprazole - 13C as a probe for determining CYP2C19 phenotype. Pantoprazole, 5-(difluoromethoxy)-2-\[\[(3,4-dimethoxy-2-pyridyl)-methyl\]sulfinyl\]-1H -benzimidazole, is a substituted benzimidazole sulfoxide and a selective and long-acting proton pump inhibitor. This drug is widely used clinically in the treatment of severe gastroesophageal reflux disease, and for treatment of duodenal and gastric ulceration. Pantoprazole is extensively metabolized in the liver, with almost 80% of an oral or intravenous dose is excreted as metabolites in urine. The main metabolite is formed by O-demethylation at the 4-position of the pyridine ring by CYP2C19, followed by conjugation with sulphate (M2), while pantoprazole sulfone formed by CYP3A represents a minor metabolic pathway(20). The critical role of CYP2C19 in the in vivo clearance of the drugs is further demonstrated by the fact that healthy volunteers that are PMs of this enzyme achieve approximately 6-fold higher pantoprazole exposure than those who are extensive metabolizers of CYP2C19(20). This concept proposal exploits the use of the 13C-label that is incorporated at the O-methyl site of pantoprazole, which specifically designed for the CYP2C19-mediated O-demethylation (Figure 1). Then, during catalysis, CYP2C19-pantoprazole reaction in the liver results in the release of 13CO2 which is then eliminated from the body via the lung expired breath. The subsequent quantification of 13CO2 allows indirect determination of the hepatic CYP2C19 enzyme and thus the pharmacokinetics of its substrates. The salient features of the 13C-breath test means that this test would be non-invasive, non-radioactive, safe and simple. The protocol in general can be performed rapidly (one hour or less after pantoprazole administration) and can be determined directly at the point of care (e.g., hospitals and physicians' offices) using relatively inexpensive instrumentation (UBiT-IR300IR spectrometer; Meretek), and patients do not require waiting for hours or days for diagnostic results. This test may be particularly important to probe the activity of CYP2C19 for infants, children, pregnant and lactating women, seniors averse to the use of needles or in poor health and subjects scared of blood draws.

Healthy

CYP2C19 Pantoprazole Genotype Pharmacokinetics Metabolism

null

3

arm 1: CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19\*1/\*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test. arm 2: CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (\*2 and \*3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test. arm 3: Homozygous for CYP2C19 null alleles (\*2/\*2, \*2/\*3 or \*3/\*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: \[13C\]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes

intervention 1: [13C]Pantoprazole

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00668902

[ 2 ]

44

RANDOMIZED

FACTORIAL

null

0NONE

false

0ALL

true

Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response. Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.

null

Scoliosis

dexmedetomidine neuromonitoring spine procedures safe dose 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials

null

5

arm 1: Dexmedetomidine low infusion, Propofol low infusion arm 2: Dexmedetomidine high infusion, Propofol low infusion arm 3: Dexmedetomidine high infusion, Propofol high infusion arm 4: Dexmedetomidine intermediate infusion, Propofol intermediate infusion arm 5: Dexmedetomidine low infusion, Propofol high infusion

[ 1, 1, 1, 1, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M intervention 2: Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M intervention 3: Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M intervention 4: Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M intervention 5: Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min

intervention 1: low dexmedetomidine, low propofol intervention 2: high dexmedetomidine, low propofol intervention 3: Dexmedetomidine intervention 4: Dexmedetomidin intervention 5: Dexmedetomidine

1

Cincinnati | Ohio | United States | -84.51439 | 39.12711

0

NCT00671931

[ 3 ]

9

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.

null

Melanoma

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: * Temozolomide: 200mg/m\^2, daily, PO, days 1-4 * Vinblastine: 1.5mg/m\^2, daily, IV, days 1-4 * Cisplatin: 20mg/m\^2, daily IV, days 1-4 * IL (interleukin)-2: - 18 milli-International unit (MIU)/m\^2, IVCI (intravenous continual infusion), day 1 * 9 MIU/m\^2, IVCI, day 2 * 4.5 MIU/m\^2, IVCI, days 3 \& 4 * Interferon (IFN) alpha: 5 MIU/m\^2, daily, SC (subcutaneously), days 1-5 * 5-day inpatient regimen, to be repeated every 21 days intervention 2: Temozolomide: 75mg/m\^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks

intervention 1: Concurrent decrescendo biochemotherapy regimen intervention 2: Low-dose Temozolomide plus Sorafenib

0

null

0

NCT00673361

[ 3 ]

106

NA

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

false

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Congenital Hyperinsulinism Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy CHI PHHI

Congenital Hyperinsulinism Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy CHI PHHI F-DOPA L-fluoro-dihydroxyphenylalanine

null

1

arm 1: Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.

[ 0 ]

2

[ 0, 4 ]

intervention 1: 0.08-0.16 mCi/kg once intervention 2: None

intervention 1: F-DOPA intervention 2: PET scan

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00674440

[ 3 ]

137

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

null

Restless Legs Syndrome

pregabalin, RLS, efficacy, safety

null

6

arm 1: Placebo arm 2: investigational treatment arm 3: investigational treatment arm 4: investigational treatment arm 5: investigational treatment arm 6: investigational treatment

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

6

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

intervention 1: Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks intervention 2: 50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 3: 100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 4: 150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 5: 300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 6: 450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

intervention 1: placebo intervention 2: Pregabalin intervention 3: Pregabalin intervention 4: Pregabalin intervention 5: Pregabalin intervention 6: Pregabalin

25

0

NCT00676403

[ 5 ]

33

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

This will be a single center, randomized, double-blind study consisting of two 2-week treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators. Eligible patients who complete the one week screening phase will be randomized to one of two treatment sequences: 1) Formoterol --\> Formoterol + Tiotropium or 2) Formoterol + Tiotropium --\> Formoterol. During the treatment periods, patients will be allowed to use a short-acting beta2-adrenergic+short-acting anticholinergic as rescue medication (salbutamol+ipratropium via MDI)

Pulmonary Disease, Chronic Obstructive Chronic Bronchitis Pulmonary Emphysema

Pulmonary Disease, Chronic Obstructive Tiotropium Formoterol Bronchodilator Agents Exercise Tolerance Randomized Controlled Trial [Publication Type] COPD

null

2

arm 1: Formoterol plus Placebo (Tiotropium) arm 2: Formoterol plus Tiotropium

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks. intervention 2: Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.

intervention 1: Formoterol plus Placebo (Tiotropium) intervention 2: Formoterol plus Tiotropium

1

São Paulo | São Paulo | Brazil | -46.63611 | -23.5475

0

NCT00680056

[ 4 ]

572

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether Sativex® versus Placebo is effective in the relief of symptoms of spasticity in subjects with multiple sclerosis, who have been identified as having a capacity to respond to Sativex.

This 19 week, multicentre study was conducted in two phases. Phase A was a preliminary, single-blind four week treatment period to identify subjects with a capacity to respond to Sativex; eligible, consenting subjects entered a seven day screening period prior to returning to the study centre to begin a four week single-blind course of Sativex treatment. At the end of this phase, subjects' response to Sativex was assessed; those with the capacity to respond (i.e. at least a 20% reduction in mean 0-10 point numerical rating scale (NRS) spasticity score between screening and the end of the four week Phase A treatment) were eligible for entry into Phase B while those who did not respond took no further part in the study other than a follow up visit 14 days later. Phase B was a 12 week double-blind, randomised, placebo controlled, parallel group study with visits at 28 day intervals and a final follow up visit 14 days after completion or withdrawal. The level of spasticity, spasm frequency and sleep disruption were collected each day during the entire study via an interactive voice response system (IVRS). In addition, study medication dosing data were recorded via IVRS throughout Phases A and B. Assessments of other secondary and functional measures of spasticity, safety and tolerability, QOL (quality of life) and mood were also gathered throughout the study.

Spasticity Multiple Sclerosis

null

2

arm 1: Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L. Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours arm 2: Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg) intervention 2: containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colouring FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).

intervention 1: Sativex® intervention 2: Placebo

1

Cliftonville | Northampton | United Kingdom | -5.93333 | 54.61667

0

NCT00681538

[ 2 ]

200

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

This study is to evaluate the oral tolerability of a nicotine prototype

null

Healthy Volunteer Smokers

Nicotine Tolerability NRT

null

2

arm 1: Marketed nicotine replacement therapy product arm 2: Nicotine prototype

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Marketed nicotine replacement therapy formulation intervention 2: Nicotine prototype

intervention 1: Nicotine intervention 2: Nicotine

0

null

0

NCT00682461

[ 0 ]

24

RANDOMIZED

CROSSOVER

6HEALTH_SERVICES_RESEARCH

1SINGLE

true

0ALL

true

The purpose of the study is to determine if giving isosorbide,a drug that is used to treat chest pain, affects blood vessel release of an anti-clotting factor.

To test the hypothesis that the administration of the NO donor isosorbide dinitrate,but not the phosphodiesterase inhibitor sildenafil, will attenuate stimulated vascular t-PA release whereas both agents will improve glucose uptake.

Obesity

Bradykinin Obesity Nitric Oxide Donor tissue type plasminogen activator isosorbide dinitrate phosphodiesterase inhibitor Renin-Angiotensin Aldosterone System Fibrinolysis Angiotensin converting enzyme

null

4

arm 1: Bradykinin (Clinalfa AG, Läufelfingen, Switzerland) arm 2: N-monomethyl-L-arginine (L-NMMA, NO synthase inhibitor; Bachem, Torrance, CA) arm 3: Isosorbide (NO donor) arm 4: Sildenafil (phosphodiesterase type 5 (PDE5) inhibitor

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Graded doses of bradykinin (Clinalfa AG, Läufelfingen, Switzerland) will be infused at 50, 100, and 200ng/min. Each dose will be infused for 5 minutes and FBF will measured during the last 2 minutes of infusion. Arterial and venous blood samples will be obtained for measurement of net t-PA release after each dose. intervention 2: Thirty minutes after administration of bradykinin a continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be started started. While continuing the infusion of L-NMMA, baseline measurements and infusion of bradykinin will be repeated. intervention 3: Following the second bradykinin infusion, 12 subjects will receive 5mg isosorbide dinitrate (an exogenous NO donor; Major Pharmaceuticals Inc, Livonia MI). Sixty minutes after the administration of isosorbide the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated. intervention 4: Following the second bradykinin infusion, 12 subjects will receive 50mg sildenafil (phosphodiesterase type 5 (PDE5) inhibitor to increase cGMP without increasing NO; Pfizer, NY). Sixty minutes after the administration of sildenafil the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated.

intervention 1: Control (bradykinin) intervention 2: L-NMMA + bradykinin intervention 3: Isosorbide + L-NMMA + bradykinin intervention 4: Sildenafil + L-NMMA + bradykinin

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00685945

[ 5 ]

393

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.

null

Hypertension

null

2

arm 1: Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. arm 2: Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

[ 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

intervention 1: Valsartan/amlodipine 80/5 mg tablets intervention 2: Amlodipine 5 mg capsules intervention 3: Amlodipine 10 mg capsules intervention 4: Atenolol 50 mg tablets intervention 5: Atenolol 100 mg tablets

1

Rueil-Malmaison | N/A | France | 2.18967 | 48.8765

0

NCT00687973

[ 5 ]

24

RANDOMIZED

SINGLE_GROUP

1PREVENTION

2DOUBLE

false

0ALL

true

A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo

null

Crohn's Disease

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6 intervention 2: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

intervention 1: infliximab intervention 2: placebo

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00688636

[ 0 ]

7

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine the efficacy of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg and to assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs. Also to determine the side effects of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells.

null

Hematologic Malignancies

null

1

arm 1: All eligible patients will receive chemotherapy and one dose of Pegfilgrastim

[ 0 ]

1

[ 0 ]

intervention 1: Pegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy).

intervention 1: Pegfilgrastim

1

Lebanon | New Hampshire | United States | -72.25176 | 43.64229

0

NCT00689884

[ 5 ]

130

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

false

Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

null

Seasonal Allergic Rhinitis

Rhinitis Seasonal Allergic Rhinitis allergies

null

2

arm 1: Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily arm 2: Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily intervention 2: Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

intervention 1: Olopatadine HCL Nasal Spray, 0.6% intervention 2: Fluticasone Propionate Nasal Spray, 50 mcg

1

Sacramento | California | United States | -121.4944 | 38.58157

0

NCT00691665

[ 3 ]

125

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.

null

Fibromyalgia

null

3

arm 1: In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. arm 2: In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. arm 3: In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.

[ 2, 0, 1 ]

3

[ 0, 0, 0 ]

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

intervention 1: Desvenlafaxine Sustained Release (DVS SR) intervention 2: Lyrica® (Pregabalin) intervention 3: Placebo

27

0

NCT00696787

[ 4 ]

36

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from treatment with Sativex®.

This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®. Subjects will be selected from the Supply of Unlicensed Sativex® (SUS) or named patient supply programmes and must have been receiving Sativex® for at least 12 weeks prior to study entry. Following informed consent and screening, eligible subjects will enter the study (Visit 1, Day 1) and commence a seven day open label baseline period, before returning for a randomisation visit (Visit 2, Day 7), at which point they are randomised to receive either Sativex® or placebo (randomised withdrawal period). Subjects will return to the centre for an end of study visit at week five (Visit 3, Day 35) or earlier if they withdraw from treatment. Spasticity and sleep disruption review and dosing diaries will be completed each day from the start of the baseline period until completion or withdrawal.

Spasticity Multiple Sclerosis

null

2

arm 1: Sativex arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: containing delta-9-tetrahydrocannabinol (THC)(27 mg/ml):cannabidiol (CBD)(25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief intervention 2: Contains no active drug and is delivered in 100 microlitre actuations by a pump action oromucosal spray

intervention 1: Sativex intervention 2: Placebo

1

Gorleston-on-Sea | Norfolk | United Kingdom | 1.73069 | 52.57301

0

NCT00702468

[ 3 ]

157

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

true

This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability.

DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study is to determine if 1-year administration of DP001 to postmenopausal women with osteopenia results in a significant increase in BMD at doses that are safe and well tolerated.

Osteoporosis

Osteoporosis 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3 Vitamin D Bone Density Conservation Agents Bone Regeneration

null

3

arm 1: None arm 2: 220 ng arm 3: 440 ng

[ 2, 0, 0 ]

2

[ 0, 0 ]

intervention 1: oral, once daily intervention 2: oral, once daily

intervention 1: Placebo intervention 2: DP001

9

0

NCT00715676

[ 3 ]

7

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.

null

Soft Tissue Sarcoma

Soft Tissue Sarcoma CC-4047 Pomalidomide

null

1

arm 1: 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Pomalidomide

3

0

NCT00717522

[ 3 ]

31

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.

The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the IC bolus administration of eptifibatide vs. IC placebo (saline) as assessed with quantitative coronary angiography (QCA).

ST-Elevation Myocardial Infarction

eptifibatide Integrilin ST-Elevation Myocardial Infarction Acute Myocardial Infarction

null

2

arm 1: Intracoronary injection of eptifibatide arm 2: Intra-coronary injection of normal saline.

[ 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Intra-coronary injection, weight based, of eptifibatide. intervention 2: Intra-coronary injection, based on weight, of eptifibatide intervention 3: Intra-coronary injection, weight based, of normal saline.

intervention 1: eptifibatide intervention 2: eptifibatide intervention 3: normal saline

3

0

NCT00719914

[ 3 ]

81

null

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049. The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Major Depressive Disorder

depression combination

null

1

arm 1: BCI-024 and BCI-049

[ 0 ]

1

[ 0 ]

intervention 1: BCI-024 and BCI-049 once a day at bedtime for 6 weeks

intervention 1: Combination Product: BCI-024 + BCI-049

9

0

NCT00731653

[ 4 ]

106

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The Electronic Device - The RebiSmart™ is an electronic injection device that is being studied for the delivery of Merck Serono's Rebif® New Formulation. The RebiSmart™ device is a stand-alone hand-held device with internal power supply. It is used for subcutaneous (under the skin) injections with single-use sterile disposable needles. The device will be kept in a storage box and placed in the refrigerator after each use. The key features of the RebiSmart™ are as follows: * Battery powered electromechanical automatic injector; * Automatic needle attachment and detachment; * Hidden needle before and after injection; * Injection can only be initiated by pressing the injection button when in contact with the skin; * Automatic needle insertion and injection of the preset dose into the subcutaneous (under the skin) tissue; * Adjustable injection comfort parameters: Injection depth, needle insertion speed, medication injection speed and time that the needle remains in the skin ; * Cartridges with 3 doses of Rebif® New Formulation; and * Several other electronic functions including history (date and time) of cartridge changes and injections. The Study Drug - Rebif® New Formulation (RNF) Rebif® is a medicine that is part of a family of proteins called interferon beta-1a (IFN-β-1a) molecules that play an important role in the immune system and help limit the damage that occurs with multiple sclerosis (MS). The interferon in Rebif® is like your body's own natural human interferon, but is made outside the body by a process called "recombinant DNA technology". Merck Serono International S.A. (the maker of Rebif®) has recently updated the method to make Rebif®, and it is referred to as Rebif® New Formulation (RNF). For the purpose of this study, the form of Rebif® New Formulation (RNF) will differ slightly from the one you currently receive. RNF will be supplied in pre-filled cartridges containing three doses of 44mcg / 0.5 ml IFN-β-1a. This is the amount required for you to administer during the course of one full week of treatment. The dosage of RNF 44mcg is injected under the skin three times per week. The RebiSmart™ device will be provided for the administration of RNF. RNF should be administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days (e.g. Monday, Wednesday, and Friday), with at least 48 hours break between each administration. You will be asked to record the time and date of each injection in the diary cards provided. You will be taught how to properly use the device to inject the medication. You will also be reminded to rotate injection sites and advised on the importance of avoiding already inflamed areas for future injections. The goals of this research trial are: * To evaluate if the electronic device can be used (if it is suitable) by MS patients performing self-injections of Rebif® New Formulation. * To determine MS patients overall satisfaction of the new RebiSmart™ device by determining their ease in using it, how often side effects happen (flu-like symptoms, injection site reactions and any other overall injection issues) that they may experience while on the trial. This will be done by completion of the Patient User Trial Questionnaire and the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ). * To evaluate specific features of the RebiSmart™ device from the answers MS patients provide in the User Trial Questionnaire. The MS patient and the person who will trains them on the proper use of the device will complete this questionnaire.

null

Multiple Sclerosis

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: RNF 44 mg, 3 times a week by subcutaneous injection.

intervention 1: Rebif® New Formulation (RNF) using RebiSmartTM

6

0

NCT00735007

[ 2, 3 ]

20

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Primary Objectives: The primary objectives of this study are as follows: • To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non small cell lung cancer (NSCLC). • To evaluate the efficacy of the combination with ABT-751 and carboplatin in patients with advanced NSCLC • To determine the median survival in the study population Secondary Objectives The secondary objectives are: • To characterize the pharmacokinetic profile of ABT-751 given in combination with carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2. • To determine the pharmacodynamics of ABT-751 as a single agent and the combination of ABT-751 and carboplatin as evaluated by cell cycle analysis of buccal mucosa cells.

This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID (twice daily) on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID. Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Grade 2 toxicity, an additional 2 patients will be enrolled at the same dose level. If 1 of the 3 patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded to 6 patients. However, if 1 patient completes one cycle at the assigned dose regimen without experiencing a Grade 2 toxicity, enrollment in the next cohort (dose level 2) can begin. This rapid dose escalation scheme will apply to cohorts 1 through 3. Initially, in the 4th cohort (dose level 4), a minimum of three patients will be enrolled. If 1 of the 3 patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded to 6 patients. However, if 3 patients complete one cycle at the assigned dose regimen without experiencing a Grade 3 (or higher toxicity), enrollment in the next cohort (dose level 5) can begin. This scheme will apply to cohorts 4, 5, and 6 MTD is defined as the highest dose of ABT-751 given in combination with carboplatin at which fewer than 33% of patients experience DLT. MTD will be evaluated at the end of the first cycle (21 days). Toxicities will be determined also at the end of cycle 2 to evaluate the safety of combining both agents on day 1. If the MTD has not been determined after completion of the 6th cohort (dose level 6), based on an overall review of toxicity at each cohort, the Investigator may select a dose thought to be the recommended dose for Phase 2 studies. Six patients treated at MTD will undergo PK (pharmacokinetic) and PD (pharmacodynamic) evaluation. An additional cohort of 14-20 patients will be enrolled at either the MTD or at the recommended Phase 2 dose level administering both drugs on day 1. During this portion of the study patients will be withdrawn from the study if any of the following occur: • Patient or patient's legally acceptable representative decides to withdraw consent. • Patient's response to therapy is unsatisfactory, as evidenced by progression of disease as defined by RECIST Criteria for Tumor Response (within 2 cycles) • The patient experiences toxicities deemed possibly or probably related to drug that have not resolved to at least Grade 2 or lower within three weeks. • The patient requires more than one dose reduction because of toxicities attributable to ABT-751. • The patient requires during the study period alternate antineoplastin agent, concurrent radiotherapy or surgery of the only measurable site(s) of disease. • The patient becomes pregnant or begins to breast-feed. • The investigator believes it is in the best interest of the patient to discontinue study drug administration. If grade 3 or higher toxicities develop in 2 or more out of the first 6 patients who receive both drugs on day 1 on a dose level at which no such toxicities were noted on the ABT-751 day 1/carboplatin day 4 schedule, the additional patients for the second portion of the study will receive the latter schedule. If toxicities characteristic of carboplatin (myelosuppression and others) are observed at the AUC 6 dose, carboplatin dose will be lowered to AUC 4.5 and the following dose escalation schema will be employed, beginning at the same ABT-751 dose as the one at which the toxicity developed: All patients should receive antiemetics prior to carboplatin. A regimen of dexamethasone 10 mg and dolasetron 100 mg IV prior to carboplatin infusion may be used. The study enrollment will be limited to patients with advanced NSCLC. Treatment will continue until progression of disease, unacceptable toxicities or withdrawal of informed consent. Male and female cancer patients will be selected to participate in the study according to the selection criteria.

Non Small Cell Lung Cancer Lung Cancer

Lung Cancer Advanced Lung Cancer NSCLC

null

3

arm 1: 100 mg BID ABT-751 orally for 7 days. Carboplatin AUC 4.5 once every 21 days. arm 2: 125 mg BID ABT-751orally for 7 days. Carboplatin AUC 4.5 or 6 once every 21 days. arm 3: 150 mg BID ABT-751orally for 7 days. Carboplatin AUC 6 once every 21 days.

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID.

intervention 1: ABT-751 and Carboplatin

1

Lebanon | New Hampshire | United States | -72.25176 | 43.64229

0

NCT00735878

[ 4 ]

321

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).

This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.

Pain

Chronic pain Acetoaminophen Tramadol Osteoarthritis of the knee Low back pain

null

3

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

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets). intervention 2: Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose \[number of tablets\] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks. intervention 3: Matching placebo will be given up to 4 weeks.

intervention 1: Tramadol Hydrochloride Plus Acetaminophen (Open-Label) intervention 2: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) intervention 3: Placebo (Double-Blind)

20

Aichi | N/A | Japan | 130.62158 | 32.51879 Amagasaki | N/A | Japan | 135.41667 | 34.71667 Chiba | N/A | Japan | 140.11667 | 35.6 Edogawa City | N/A | Japan | 139.87308 | 35.69225 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fukushima | N/A | Japan | 140.46667 | 37.75 Iruma | N/A | Japan | 139.368 | 35.818 Kagoshima | N/A | Japan | 130.55 | 31.56667 Kawasaki | N/A | Japan | 139.71722 | 35.52056 Kumagaya | N/A | Japan | 139.39004 | 36.13497 Kurume | N/A | Japan | 130.51667 | 33.31667 Meguro City | N/A | Japan | 139.70174 | 35.6322 Minato | N/A | Japan | 135.1501 | 34.2152 Niigata | N/A | Japan | 139.04125 | 37.92259 Ohta-Ku | N/A | Japan | N/A | N/A Okazaki | N/A | Japan | 137.16667 | 34.95 Sagamihara | N/A | Japan | 139.24167 | 35.56707 Setagaya City | N/A | Japan | 139.64715 | 35.64188 Shibuya City | N/A | Japan | 139.70665 | 35.6589 Shinjuku-Ku | N/A | Japan | N/A | N/A

0

NCT00736853

[ 3 ]

51

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the body and either Dovonex® cream or cream vehicle to lesions on the other side.

null

Psoriasis Vulgaris

null

3

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

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Once daily application intervention 2: Twice daily application intervention 3: Twice daily application

intervention 1: LEO 19123 Cream (calcipotriol plus LEO 80122) intervention 2: Dovonex® cream intervention 3: Cream vehicle

1

Barrie | Ontario | Canada | -79.66634 | 44.40011

0

NCT00764751

[ 5 ]

180

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

2MALE

true

Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production in healthy males. The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of minocycline, compared with a placebo or inactive pill. Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2 treatment groups with approximately 85 subjects per group. You will be treated with either Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14 days prior to the first dose of study drug. Required study activities include: * Written informed consent * Weight * Two semen collections within 48-72 hours of one another at the screening visit and Days 84,112, 140, and 168 * Blood draws at the screening visit and Days 84, 112, 140, and 168 * Genital examination (excluding prostate) at screening and at the Day 84 and Day 112 visits * Medical history You will continue in the treatment phase of the study for 12 weeks. You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of the study, with the final study visit approximately 12 weeks after the last dose. Participation will be for 24-weeks. Up to 10 investigational sites will enroll subjects into the study.

null

Human Volunteer

Spermatogenesis in Healthy Males

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 1 mg/kg extended release minocycline HCL, once daily for 84 days. intervention 2: placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.

intervention 1: minocycline extended release intervention 2: Placebo

10

0

NCT00765336

[ 2, 3 ]

27

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

true

0ALL

true

The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin.

Although aspirin has been a stalwart treatment in the prevention and treatment of myocardial infarction and stroke, it does not have its expected effects in a significant proportion of the population. This phenomenon has been termed "aspirin resistance". Omega-3 fatty acid supplementation has been associated with a reduced risk of sudden cardiac death and myocardial infarction. The beneficial effects of omega-3s are considered to be partially due to their ability to prevent platelet aggregation. However, the ability of omega-3s to enhance the effects of aspirin in those who suffer from aspirin resistance has not been determined. It is known that aspirin stimulates the production of potent lipid mediators from omega-3 fatty acids and that these mediators have powerful antiinflammatory and tissue-protective effects. Thus, the treatment of individuals at high risk for myocardial infarction and stroke with both aspirin and a pharmaceutical-grade omega-3 fatty acid medication may be a powerful combination in the prevention and treatment of life-threatening cardiovascular disease. Study Protocol: Non-smoking male and female subjects between the ages of 18 and 50 not taking any medications, vitamin pills, nutritional supplements, or herbal preparations were recruited. Subjects with a history of chronic diseases (e.g. cardiovascular, renal, hepatic, neurodegenerative, neoplastic, metabolic {diabetes}, hypertension; based on screening medical history, a complete blood count, and comprehensive metabolic profile), or allergic reactions to aspirin, fish, fish oils, or non-steroidal anti-inflammatory drugs were excluded. Other exclusions included drinking more than three alcoholic beverages a day, or having any of the following conditions: an ulcer or bleeding in the stomach, liver or kidney disease, bleeding or blood clotting disorder (e.g. hemophilia), congestive heart failure, fluid retention, high blood pressure, gout, asthma, arthritis, or nasal polyps. This was a randomized, placebo-controlled, double-blinded trial with a cross-over design. Each subject served as his/her own control. The study involved four visits four weeks apart, all hosted in the University of Rochester Clinical Research Center. At each separate study visit, each subject received (using a randomized protocol) placebo, 81 mg aspirin, 4 g Lovaza(R)(3.4g of EPA+DHA), or both aspirin and Lovaza(R). Thus, each subject received each of these treatments individually in a random fashion over the four visits. Subjects, Center staff, and investigators were blinded as to which treatment was given at each visit and this ensured by the study pharmacist making the tablets and capsules for each treatment appear identical. Prior to each visit, subjects ate a standard low-fat dinner the prior evening, then fasted for at least 8 hours prior to arrival at the Center. Subjects were required to abstain from taking aspirin or non-steroidal anti-inflammatory drugs for 10 days prior to each visit and omega-3 fatty acids for 30 days prior to the baseline study visit, and all subsequent clinic visits. Visits lasted approximately 6 hours, with subjects at bedrest. A venous catheter was placed in a peripheral vein (saline lock, 18 gauge or larger, {no heparin used} in the forearm) with blood drawn, at baseline and 4 hours post-treatment, into citrated tubes at each visit for Platelet Function Analyzer-100 (PFA-100-Siemens, Deerfield, IL) closure time testing. Subjects were provided with a standard low-fat breakfast after the baseline phlebotomy.

Increased Drug Resistance

aspirin omega 3 fatty acids Lovaza myocardial infarction aspirin resistance cardiovascular disease

null

4

arm 1: First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin arm 2: First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo arm 3: First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin arm 4: First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 10 ]

intervention 1: Aspirin 81mg tablet intervention 2: Lovaza 4 grams intervention 3: Lovaza 4 grams plus aspirin 81 mg intervention 4: Capsule resembling fish oil and a tablet resembling aspirin

intervention 1: Aspirin intervention 2: Lovaza intervention 3: Both Aspirin and Lovaza intervention 4: Placebo

1

Rochester | New York | United States | -77.61556 | 43.15478

0

NCT00771914

[ 0 ]

10

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

true

This study is a split face, paired-comparison, pilot study of 10 subjects. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from the clinic, as well as advertising and from previous Institutional Review Board (IRB) approved acne studies housed in the Department of Dermatology. All subjects accrued from previous studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face, and meeting inclusion criteria will be eligible to participate.

Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules). The basic cause of acne remains unknown, but its manifestations are thought to be the product of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diptheroid normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by the action of chemotactic factors and various enzymes, and initiated in part by the interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle gives rise to the microcomedo that is thought to be the precursor lesion of acne. Topical benzoyl peroxide is a common and well-established agent with known antibacterial and antimicrobial properties used in the treatment of acne vulgaris. The safety profile for topical benzoyl peroxide has been well delineated. The most common side effects attributed to benzoyl peroxide products include irritation, dryness, scaling, burning and stinging. Benzoyl peroxide 10.0% creams (Formulation #1 and Formulation #2) will be evaluated to detect any differences in their response for safety and efficacy.

Acne Vulgaris

Acne

null

2

arm 1: Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to left side of the face. arm 2: Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to right side of the face.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily. intervention 2: Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.

intervention 1: Topical benzoyl peroxide 10.0% cream - Formulation 1 intervention 2: Topical benzoyl peroxide 10.0% cream - Formulation 2

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00787943

[ 3 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

1FEMALE

false

This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.

Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.

Phase 1 Pharmacodynamic Study

null

4

arm 1: Intervention: Oral rsCT tablet given once 4 hours after evening meal. arm 2: Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal arm 3: Intervention: Oral rsCT tablet given once 2 hours after evening meal. arm 4: Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal

[ 0, 2, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description. intervention 2: Part 1, Double blind oral placebo tablet given once 4 hours after evening meal. intervention 3: Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal. intervention 4: Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.

intervention 1: Oral rsCT tablet intervention 2: Oral Placebo Tablet intervention 3: Oral rsCT tablet intervention 4: Fortical (rsCT) nasal spray

1

Springfield | Missouri | United States | -93.29824 | 37.21533

0

NCT00803686

[ 5 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.

null

Dehydration

dehydration fluid therapy hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rHuPH20

null

9

arm 1: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with Tegaderm arm 2: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with a tape double chevron arm 3: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with Tegaderm arm 4: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with a tape double chevron arm 5: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with Tegaderm arm 6: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with a tape double chevron arm 7: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with Tegaderm arm 8: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with a tape double chevron arm 9: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a button-type subcutaneous delivery system (with a 27-gauge, 9 mm long metal needle)

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

1

[ 0 ]

intervention 1: single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

intervention 1: hylenex-facilitated subcutaneous Lactated Ringer's infusion

2

0

NCT00807885

[ 4 ]

150

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.

null

Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting palonosetron pediatric

null

2

arm 1: Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg) arm 2: Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: palonosetron IV 1 mcg/kg intervention 2: palonosetron 3mcg/kg IV

intervention 1: palonosetron intervention 2: palonosetron

13

Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Cherkassy | N/A | Ukraine | 32.05738 | 49.44452 Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664 Donetsk | N/A | Ukraine | 37.80224 | 48.023 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 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826

0

NCT00828295

[ 5 ]

30

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol propionate foam in subjects with chronic dermatitis.

The study is being conducted in order to obtain safety, efficacy and tolerability data for Clobetasol propionate foam in the treatment of chronic dermatitis. The subjects must have mild to moderate disease based on the Investigator's assessment at baseline.

Hand Dermatosis

Dermatosis, Dermatitis, Dry skin, Irritated skin

null

1

arm 1: All subjects receive clobetasol propionate

[ 0 ]

1

[ 0 ]

intervention 1: Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.

intervention 1: clobetasol propionate

1

Louisville | Kentucky | United States | -85.75941 | 38.25424

0

NCT00828464

[ 3 ]

72

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Venous Stasis Ulcers

Venous Stasis Ulcers venous insufficiency leg ulcers Thymosin Beta 4 Laminin-5

null

2

arm 1: There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days arm 2: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days intervention 2: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

intervention 1: Thymosin Beta 4 intervention 2: Placebo

8

Bologna | N/A | Italy | 11.33875 | 44.49381 Naples | N/A | Italy | 14.26811 | 40.85216 Padua | N/A | Italy | 11.88586 | 45.40797 Padua | N/A | Italy | 11.88586 | 45.40797 Rome | N/A | Italy | 12.51133 | 41.89193 Lublin | N/A | Poland | 22.56667 | 51.25 Szczecin | N/A | Poland | 14.55302 | 53.42894 Wroclaw | N/A | Poland | 17.03333 | 51.1

0

NCT00832091

[ 5 ]

54

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.

Acne

Acne Vulgaris Acne

null

2

arm 1: Clindamycin and benzoyl peroxide gel arm 2: Clindamycin and tretinoin gel

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks intervention 2: Clindamycin and tretinoin gel once a day for 12 weeks.

intervention 1: Duac intervention 2: Ziana gel

2

0

NCT00841776

[ 0 ]

20

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment, developmental disability and autism. Minocycline is an antibiotic that has recently been used to treat the mouse model for Fragile X, and was found to reverse the structural abnormalities that are seen their brain cells. The purpose of this research study is to determine if minocycline is an effective treatment for patients with fragile X syndrome (FXS).

Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment and is also associated with a range of learning disabilities, neurological problems, such as seizures, and behavioural difficulties. For many individuals with FXS, behavioral difficulties result in severe problems within the family and community, particularly in the form of agitation, temper outbursts, hyperactivity, and aggression. These problems often require a variety of psychopharmacological and behavioural approaches. Although a variety of medications can be helpful in FXS there are no targeted interventions based on molecular abnormalities that have been studied. Defects in dendritic spine formation have been found in the brains of patients with Fragile X, suggesting these structures may represent an anatomical and physiological basis for the cognitive deficits associated with this disorder. Recent research has suggested that minocycline may have a specific benefit in the treatment of FXS. Minocycline is an antibiotic that has been found to inhibit the activity of matrix metallo-proteinase-9 (MMP-9), which is up-regulated in the hippocampus of FMR1 KO (Fragile X Mental Retardation-1 Knockout) mice and may be responsible for the immature dendritic spine profile of hippocampal neurons. Minocycline has recently been used to treat the FXS KO mouse model for Fragile X, and was found to rescue this abnormal phenotype by inducing the formation of mature dendritic spines in FMR1 KO hippocampal neurons, both in vitro and in vivo. Minocycline treated FXS KO mice also performed significantly better in the elevated maze, a cognitive performance test that measures activity and anxiety. Exciting preclinical effects of minocycline with regard to the FXS disease model have led to this pilot proposal, which is designed to generate preliminary data that could be used to support a larger clinical trial. The overall hypothesis is that minocycline is a specific molecular targeted treatment for FXS that will display beneficial effects on disruptive behaviour and possibly other associated features of FXS via a reduction in MMP-9 activity.

Fragile X Syndrome

Clinical Drug Trial

null

1

arm 1: open label treatment with minocycline low or high dose, 50 mg or 100 mg PO (by mouth) BID (twice a day), added to existing medication regimen for 8 weeks

[ 0 ]

1

[ 0 ]

intervention 1: 50-100 mg PO BID for 8 weeks with an option for a 1 year extension.

intervention 1: Minocycline

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT00858689

[ 2 ]

6

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantities of 14C-labeled MK-0941.

null

Type 2 Diabetes

null

1

arm 1: MK-0941

[ 0 ]

1

[ 0 ]

intervention 1: A single dose of 40 mg of \[14C\]MK-0941 (160 µCi), taken orally as eight 5-mg capsules

intervention 1: MK-0941

0

null

0

NCT00912002

[ 2 ]

18

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic profile of cladribine, especially in terms of extent of absorption of cladribine since pH-modifying drug may potentially affect the stability of cladribine and thereby its bioavailability

null

Multiple Sclerosis

null

2

arm 1: Subjects will receive a single dose of cladribine10 milligram (mg) orally on Day 1. After a wash out period of 10-25 days, subjects will receive pantoprazole 40 mg orally for 2 consecutive days. On Day 2 of the pantoprazole administration, a single dose of cladribine 10 mg will be administered orally 3 hours after the second pantoprazole dose. arm 2: Subjects will receive pantoprazole 40 mg orally for 2 consecutive days. On Day 2 of the pantoprazole administration, a single dose of cladribine 10 mg will be administered orally 3 hours after the second pantoprazole dose. After a wash out period of 10-25 days, subjects will receive a single dose of cladribine 10 mg orally.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Subjects will receive two single doses of 10 mg cladribine orally in either first or second intervention period followed by a washout period of 10-25 days. intervention 2: Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period.

intervention 1: Cladribine intervention 2: Pantoprazole

0

null

0

NCT00938366

[ 3 ]

567

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.

null

Postherpetic Neuralgia

pain herpetic neuralgia

null

6

arm 1: ESL 400 mg twice-daily arm 2: ESL 800 mg once-daily arm 3: ESL 600 mg twice daily arm 4: ESL 1200 mg once daily arm 5: ESL 800 mg twice daily arm 6: placebo

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

2

[ 0, 0 ]

intervention 1: Scored tablets intervention 2: oral route

intervention 1: Eslicarbazepine acetate intervention 2: Placebo

0

null

0

NCT00981227

[ 4 ]

317

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.

null

Type 2 Diabetes Mellitus

null

2

arm 1: None arm 2: None

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets. intervention 2: Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets. intervention 3: Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.

intervention 1: Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d. intervention 2: Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d. intervention 3: Metformin

0

null

0

NCT01028391

[ 0 ]

86

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG \< 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.

Patients with BG \> 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Survival skills self-management education and navigation to outpatient services were provided.

Type 2 Diabetes Mellitus

Type 2 diabetes mellitus Uncontrolled hyperglycemia Emergency Department

null

1

arm 1: All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.

[ 5 ]

2

[ 0, 5 ]

intervention 1: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. intervention 2: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.

intervention 1: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin intervention 2: Diabetes survival skills self-management education

1

Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511

0

NCT01033773

[ 3 ]

387

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine a recommended dose of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically more effective) of the drug to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), and to assess if a same therapeutic effect can be observed between this study and overseas Caucasian clinical studies.

This study is a multicenter (more than 1 site), placebo-controlled (compared to placebo), randomized (participants assigned study drug by chance), double-blind (neither the participant nor the physician know the assigned study drug), parallel-group comparison (comparison for each group at the same time) study. The study period consists of 4 phases: the observation phase, double-blind phase, exit period and follow-up period. After the double-blind phase, the participants will be transferred to the continuous treatment study. The observation phase which is started after informed consent consists of the washout period (non-treatment period with migraine preventive medication: at least 2 weeks) and baseline determination period (at least 4 weeks). The participants who complete the observation phase and meet the inclusion criteria will be randomly assigned to the topiramate 50 milligram (mg) group, topiramate 100-mg group or placebo group after registration. The double-blind phase consists of the titration period (dose-escalation, 4 weeks) and fixed-dose period (18 weeks). In the titration period, starting from 1 topiramate 25-mg tablet or 1 topiramate 25-mg placebo tablet once daily (1 tablet in the evening), the dose will be increased by 1 tablet every week up to twice daily (2 tablets in the morning, 2 tablets in the evening). After that, the twice-daily treatment (2 tablets in the morning, 2 tablets in the evening) will be continued for 7 days from Day 22 to Day 28. In the fixed-dose period, the topiramate 25-mg tablets or topiramate 25-mg placebo tablets at the same dose as that in the final treatment in titration period will be continued. The participants who are not transferred to the continuous treatment study after completion of the double-blind phase or after discontinuation during the double-blind phase will be transferred to the exit period (up to 1 week).The participants who complete the exit period will be transferred to the follow-up period, and a follow-up of the participant's safety and headache symptoms such as the migraine period rate will be conducted for 4 weeks after the completion of investigational treatment. Meanwhile, the participants who complete the double-blind phase or those who discontinue the study at Week 4 or later in the fixed-dose period during the double-blind phase due to lack of efficacy and give consent to transfer to the continuous treatment study will be transferred to the transfer period (up to 3 weeks) under blind conditions.

Migraine

Topiramate Migraine

null

3

arm 1: In titration period, topiramate 25 milligram (mg) tablet will be given once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period. arm 2: In titration period, topiramate 25 mg tablet will be given once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period. arm 3: In titration period, matching placebo tablet will be given once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice orally from Day 22 to Day 28 and will becontinued further for 18 weeks in the fixed dose period.

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: In the titration period, topiramate 25-mg tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks so that the total daily dose given is 50 mg or 100mg. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period). intervention 2: In the titration period, matching placebo tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).

intervention 1: Topiramate intervention 2: Placebo

29

Bunkyō City | N/A | Japan | 139.4217 | 35.5331 Chitose | N/A | Japan | 141.65222 | 42.81944 Hachiōji | N/A | Japan | 139.32389 | 35.65583 Iruma | N/A | Japan | 139.368 | 35.818 Isehara | N/A | Japan | 139.31019 | 35.39932 Kagoshima | N/A | Japan | 130.55 | 31.56667 Kamogawa | N/A | Japan | 140.1003 | 35.0969 Kitakyushu | N/A | Japan | 130.85034 | 33.85181 Kobe | N/A | Japan | 135.183 | 34.6913 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Kyoto | N/A | Japan | 135.75385 | 35.02107 Minato | N/A | Japan | 135.1501 | 34.2152 Morioka | N/A | Japan | 141.15 | 39.7 Nagoya | N/A | Japan | 136.90641 | 35.18147 Nishinomiya | N/A | Japan | 135.33199 | 34.71562 Numakunai | N/A | Japan | 141.21667 | 39.96667 Sagamihara | N/A | Japan | 139.24167 | 35.56707 Sapporo | N/A | Japan | 141.35 | 43.06667 Shimotsuga | N/A | Japan | N/A | N/A Shinjuku | N/A | Japan | 139.70854 | 35.69115 Shinjuku-Ku | N/A | Japan | N/A | N/A Shizuoka | N/A | Japan | 138.38333 | 34.98333 Suginami-Ku | N/A | Japan | N/A | N/A Tokyo | N/A | Japan | 139.69171 | 35.6895 Toyama | N/A | Japan | 137.21667 | 36.7 Toyonaka | N/A | Japan | 135.46932 | 34.78244 Ube | N/A | Japan | 131.25111 | 33.94306 Yokohama | N/A | Japan | 139.65 | 35.43333 Yonago | N/A | Japan | 133.33333 | 35.43333

0

NCT01081795

[ 2 ]

55

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Healthy

Healthy subjects Opioid Healthy volunteers

null

2

arm 1: Reformulated OXY 10 mg (Totowa) x 1 dose arm 2: Reformulated OXY 10 mg (Wilson) x 1 dose

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state. intervention 2: Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.

intervention 1: Reformulated OXY (Totowa) (oxycodone HCl) intervention 2: Reformulated OXY (Wilson) (oxycodone HCl)

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT01101308

[ 0 ]

39

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. . Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or "no treatment" in random order, on three different occasions each. At each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved and an 11-point, self-reported scale of improvement are examined.

null

Asthma Placebo Effects

null

3

arm 1: albuterol arm 2: placebo arm 3: placebo

[ 1, 2, 2 ]

3

[ 0, 0, 3 ]

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

intervention 1: albuterol intervention 2: placebo inhaler intervention 3: placebo acupuncture

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT01143688

[ 4 ]

36

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

1FEMALE

false

To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Preterm Birth

Preterm birth, prevention, progesterone, oral

null

2

arm 1: Oral Micronized Progesterone arm 2: Identical Placebo Tablet

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks intervention 2: Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

intervention 1: oral micronized progesterone intervention 2: Identical Placebo tablet

1

Dayton | Ohio | United States | -84.19161 | 39.75895

0

NCT01180296

[ 3 ]

45

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

2DOUBLE

true

0ALL

null

The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.

The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.

Dental Anesthesia Efficacy

null

2

arm 1: 3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril arm 2: .5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg. intervention 2: Each subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays.

intervention 1: 3% tetracaine HCL with 0.05% oxymetazoline HCL intervention 2: Lidocaine Injection

1

Buffalo | New York | United States | -78.87837 | 42.88645

0

NCT01302483

[ 5 ]

544

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

Background: * While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been assessed only in the USA where the causative agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main etiologic agents are B. afzelii and B. garinii. * Controversy exists over the significance and even the existence of post-Lyme disease symptoms because of the high rate of similar background symptoms in the general population. Purpose: The two main purposes of this European, prospective clinical trial in which doxycycline and cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and which included a control group to address the significance of post-Lyme disease symptoms are: * To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the treatment of erythema migrans using clinical and bacteriological criteria (noninferiority testing approach), and * to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM with antibiotics and the frequency of similar symptoms in control subjects without Lyme disease.

Sample size Decisions were based on the following: 1. Number of patients with erythema migrans treated with doxycycline and cefuroxime axetil was determined assuming no difference in treatment outcome will be detected (non-inferiority testing). 2. The decision for a larger sample sizes than needed for 1. was done with the intention to evaluate the secondary outcome measure, i.e., to assess the difference between the frequency of new or increased symptoms in patients treated for early Lyme disease and the occurrence of the same symptoms in control subjects. 1. We assumed that the outcomes in the two treatment groups will be comparable and that the patients could be combined for further analysis. 2. To obtain a control group from the same geographical area, each patient was asked if she or he had a family member or friend who was within 5 years of her or his age and who was without a history of Lyme borreliosis. These persons were approached by a short written explanation of the investigation, containing also a request for their participation. We assumed that we will be able to get a corresponding control person not for all but for approximately 80-90% of patients. 3. Under the assumption that approximately 15% of an estimated 200 patients would have new or increased symptoms at \>6 months after enrollment into the study, a control group of 165 subjects would be sufficient to detect a \>10 percentage point lower rate of new or increased symptoms in controls compared with patients at the 0.05 level (2-sided) with \>90% power. To comply with drop outs at different time points we assessed that 280 patients and 230 controls should be included at baseline.

Erythema Migrans Post-Lyme Disease Symptoms

erythema migrans doxycycline cefuroxime axetil post-Lyme disease symptoms background symptoms in general population

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 100 mg bid; 15 days intervention 2: 500 mg bid; 15 days

intervention 1: doxycycline intervention 2: cefuroxime axetil

2

Ljubljana | N/A | Slovenia | 14.50513 | 46.05108 Ljubljana | N/A | Slovenia | 14.50513 | 46.05108

0

NCT01518192

[ 5 ]

71

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal infections (\[IPFI\]; lung diseases caused by fungal infection).

This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of itraconazole sequential therapy in participants with IPFI. The study duration will be 4 to 6 weeks. The treatment will be divided into the intravenous (into a vein) injection period and the oral solution administration (giving) period. During the intravenous injection period 200 milligram (mg) twice daily loading dose (large initial dose) will be given for first 2 days, 200 mg once daily for the subsequent 12 days. Then sequential itraconazole oral solution 200 mg twice daily will be given as maintenance therapy (treatment designed to help the original primary treatment to succeed) for 2-4 weeks. Participant's clinical, mycological and comprehensive efficacy will be assessed at Week 6. Participants' safety will be monitored throughout the study.

Pulmonary Fungal Infection

Invasive Pulmonary Fungal Infection Itraconazole

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.

intervention 1: Itraconazole

0

null

0

NCT01823289

[ 2 ]

24

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

2MALE

false

The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.

Methodology: Single-centre, open-label, parallel group, non-randomised multiple-dose 7-day study in 12 healthy elderly and 12 healthy younger male subjects. Duration of treatment: Each subject participated in the study for approximately 6 weeks. Participation included a screening evaluation within 28 days before inpatient period, a 12 day inpatient period and an end of study visit (ESV) 7 to 10 days after the discharge from the Unit. The study design followed the recommendations of the CPMP/ICH/379/95 (ICH Topic E7) Note for Guidance on Studies in Support of Special Populations: Geriatrics, namely in the inclusion of subjects aged 65 years or older and contemplating single-dose and steady-state PK profiles. As the primary endpoint of the study was to characterize the pharmacokinetic profile of BIA 9-1067 and its metabolites in different parallel groups, there was no need to implement blinding procedures or to include a control group. Consequently, the trial was an open label study. Healthy subjects rather than patients with Parkinson's disease have been chosen as the study population, due to the lack of over-toxicity of the drug and an acceptable risk-benefit ratio. This allowed for a better interpretation of the study results, as there were no confounding factors resulting from changes in disease state and or concomitant medications. The subjects were given a screening number after signing the informed consent by chronological order of inclusion in each group (young/elderly).

Parkinson Disease

Opicapone BIAL

null

2

arm 1: BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. arm 2: BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.

[ 0, 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: BIA 9-1067

1

Rueil | Malmaison | France | 1.87938 | 49.047

0

NCT02092168

[ 3 ]

2

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

true

This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.

Inclusion Criteria: 1. Diagnosis of idiopathic Parkinson's disease. 2. Age \> 40 years. 3. willingness and ability to comply with the study requirements and give informed consent.

Parkinson's Disease

Parkinson's disease PD dyskinesia treatment motor complications

null

2

arm 1: subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. arm 2: subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: sildenafil 50mg BID for 2 weeks intervention 2: None

intervention 1: sildenafil intervention 2: Placebo

1

Loma Linda | California | United States | -117.26115 | 34.04835

0

NCT02162979

[ 2 ]

12

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 controlled-release levodopa/carbidopa 100/25 mg (Sinemet® CR 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® CR 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) BIA 9-1067 Opicapone

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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 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 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.

[ 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

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

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

1

Mount Royal | Quebec | Canada | -73.64918 | 45.51675

0

NCT02169453

[ 5 ]

27

NON_RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time. Phase 2 - All remaining subjects received Iloprost as a continuous treatment. The study was designed for an enrollment of 200 subjects and was ended early.

Pulmonary Hypertension

pulmonary hypertension

null

2

arm 1: Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. arm 2: Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.

[ 0, 0 ]

1

[ 0 ]

intervention 1: A 20 mcg dose of Iloprost will be given initially.

intervention 1: Inhaled Iloprost

0

null

0

NCT02170519

[ 3 ]

55

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma.

OBJECTIVES: * Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC. * Determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients. * Determine the safety profile of this drug in these patients. * Determine the survival of patients treated with this drug. * Determine the tumor response rate in patients treated with this drug. * Determine the biological effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study.

Brain and Central Nervous System Tumors

adult anaplastic astrocytoma adult mixed glioma adult anaplastic oligodendroglioma recurrent adult brain tumor adult anaplastic ependymoma

null

1

arm 1: Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: poly ICLC

8

0

NCT00058123

[ 3 ]

99

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).

null

Neuralgia, Postherpetic

monoclonal antibody

null

3

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

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 50 mcg/kg intervention 2: 200 mcg/kg intervention 3: placebo

intervention 1: RN624 intervention 2: RN624 intervention 3: Placebo

31

0

NCT00568321

[ 3 ]

334

RANDOMIZED

FACTORIAL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.

null

Hypercholesterolemia

null

4

arm 1: 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks arm 2: 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks arm 3: 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks arm 4: 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks

[ 0, 1, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: MK-6213 160 mg for 4 weeks. intervention 2: atorvastatin calcium 20mg for 4 weeks. intervention 3: None intervention 4: None

intervention 1: MK-6213 intervention 2: Atorvastatin calcium intervention 3: Placebo for MK-6312 160 mg intervention 4: Placebo for Atorvastatin 20 mg

0

null

0

NCT00687271

[ 0 ]

18

NON_RANDOMIZED

SINGLE_GROUP

9OTHER

1SINGLE

true

0ALL

true

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.

Chronic Sinusitis

Nasal Spray Nasal Drop Intranasal Medication

null

2

arm 1: This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses. arm 2: This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.

[ 0, 0 ]

3

[ 4, 0, 0 ]

intervention 1: Subjects will undergo a Xoran miniCAT scan of their sinuses intervention 2: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml. intervention 3: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.

intervention 1: Sinus CT Scan intervention 2: Omnipaque 240 Contrast Solution intervention 3: Omnipaque 240 mg I/mL

1

Omaha | Nebraska | United States | -95.94043 | 41.25626

0

NCT00626366

[ 4 ]

21

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the study will be eligible to enrol in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-316).

null

Epilepsy

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 25-400 mg capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg; \>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks) intervention 2: 25-400 mg Zonisamide Placebo capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg Zonisamide Placebo; \>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks)

intervention 1: Zonisamide intervention 2: Placebo

73

Chatswood | New South Wales | Australia | 151.18333 | -33.8 Randwick | New South Wales | Australia | 151.24895 | -33.91439 Heidelburg | Victoria | Australia | N/A | N/A Melbourne | Victoria | Australia | 144.96332 | -37.814 Melbourne | N/A | Australia | 144.96332 | -37.814 Split | HR | Croatia | 16.43915 | 43.50891 Zagreb | HR | Croatia | 15.97798 | 45.81444 Zagreb | HR | Croatia | 15.97798 | 45.81444 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Kroměříž | N/A | Czechia | 17.39312 | 49.29785 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Prague | N/A | Czechia | 14.42076 | 50.08804 Rychnov nad Kněžnou | N/A | Czechia | 16.27488 | 50.16284 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tartu | N/A | Estonia | 26.72509 | 58.38062 Kuopio | SF | Finland | 27.67703 | 62.89238 Oulu | N/A | Finland | 25.46816 | 65.01236 Berlin | N/A | Germany | 13.41053 | 52.52437 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Marburg | N/A | Germany | 8.77069 | 50.80904 München | N/A | Germany | 13.31243 | 51.60698 Ulm | N/A | Germany | 9.99155 | 48.39841 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Gyula | N/A | Hungary | 21.28333 | 46.65 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Szombathely | N/A | Hungary | 16.62155 | 47.23088 Veszpem | N/A | Hungary | N/A | N/A Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Vilnius | N/A | Lithuania | 25.2798 | 54.68916 Bialystok | N/A | Poland | 23.16433 | 53.13333 Gdansk | N/A | Poland | 18.64912 | 54.35227 Katowice | N/A | Poland | 19.02754 | 50.25841 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Poznan | N/A | Poland | 16.92993 | 52.40692 Bucharest | N/A | Romania | 26.10626 | 44.43225 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 Iași | N/A | Romania | 27.6 | 47.16667 Iași | N/A | Romania | 27.6 | 47.16667 Tg Mures | N/A | Romania | N/A | N/A Krasnoyarsk | N/A | Russia | 92.90765 | 56.02668 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Novosibirsk | N/A | Russia | 82.94339 | 55.03442 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 Smolensk | N/A | Russia | 32.04371 | 54.77944 Smolensk | N/A | Russia | 32.04371 | 54.77944 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Kragujevac | N/A | Serbia | 20.91667 | 44.01667 Niš | N/A | Serbia | 21.90333 | 43.32472 Dniepropetrovsk | N/A | Ukraine | N/A | N/A Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Vinnitsa | N/A | Ukraine | 37.71861 | 49.84639

0

NCT00692003

[ 3 ]

46

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.

null

Akathisia, Drug-Induced Antipsychotic Agents Movement Disorders

Antipsychotic Agents

null

4

arm 1: Preladenant 25 mg every 12 hours for 13 days arm 2: Placebo every 12 hours for 13 days arm 3: Preladenant 25 mg every 12 hours for 13 days arm 4: Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)

[ 0, 2, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Preladenant, one 25 mg capsule, administered orally every 12 hours intervention 2: Matching placebo capsule administered orally every 12 hours intervention 3: Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol. Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol. intervention 4: Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

intervention 1: Preladenant intervention 2: Placebo intervention 3: Anticholinergic agents or propanolol intervention 4: Haloperidol

0

null

0

NCT00693472

[ 3 ]

38

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.

null

Dry Eye Disease

null

1

arm 1: bromfenac ophthalmic solution 0.06% bilaterally twice a day

[ 0 ]

1

[ 0 ]

intervention 1: bromfenac ophthalmic solution 0.06% bilaterally twice a day

intervention 1: bromfenac ophthalmic solution 0.06%

1

Irvine | California | United States | -117.82311 | 33.66946

0

NCT00758784

[ 3 ]

107

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.

null

Atherosclerosis

SB-480848 Dyslipidaemia

null

4

arm 1: Matched Placebo arm 2: SB480848 40mg/day arm 3: SB480848 80mg/day arm 4: SB480848 160mg/day

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1 tablet once a day intervention 2: 1 tablet once a day intervention 3: 1 tablet once a day intervention 4: 1 tablet once a day

intervention 1: SB480848 40mg EC Tablet intervention 2: SB480848 80mg EC Tablet intervention 3: SB480848 160mg EC Tablet intervention 4: SB480848 Placebo Tablet

7

Fukuoka | N/A | Japan | 130.41667 | 33.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 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

0

NCT00734032

[ 2 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

1FEMALE

null

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

null

Overactive Bladder

null

4

arm 1: Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo arm 2: Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd) arm 3: Part II, Sequence 1: study drug crossing over to placebo arm 4: Part II, Sequence 2: placebo crossing over to study drug

[ 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule intervention 2: Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

intervention 1: tolterodine tartrate intervention 2: Comparator: Placebo to tolterodine tartrate

0

null

0

NCT00768521

[ 3 ]

37

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.

This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those participants who meet all eligibility requirements will be enrolled in the study. Treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. Originally, participants were receiving treatment for up to 7 days. Then after Protocol Amendment 1 (12 March 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days".

Opioid-induced Constipation

null

2

arm 1: Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled. arm 2: Participants will receive placebo matching to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. intervention 2: Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

intervention 1: Methylnaltrexone bromide intervention 2: Placebo

1

Tarrytown | New York | United States | -73.85875 | 41.07621

0

NCT00640146

[ 4 ]

116

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

null

Digital Ulcers

digital ulcers systemic sclerosis finger ulcers bosentan open label

null

1

arm 1: Bosentan 62.5 mg tablets b.i.d. for the first 4 weeks followed by bosentan 125 mg b.i.d. thereafter

[ 0 ]

2

[ 0, 0 ]

intervention 1: Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose) intervention 2: Bosentan 125-mg oral tablets administered b.i.d. (target dose)

intervention 1: Bosentan 62.5 mg intervention 2: Bosentan 125 mg

0

null

0

NCT00319696

[ 4 ]

1,068

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.

null

Migraine

null

2

arm 1: Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. arm 2: Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.

[ 0, 1 ]

6

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

intervention 1: One capsule taken orally at onset of migraine intervention 2: One tablet taken orally at onset of migraine intervention 3: One tablet taken orally at onset of migraine intervention 4: One capsule taken orally at onset of migraine intervention 5: One tablet taken orally at onset of migraine intervention 6: One tablet taken orally at onset of migraine

intervention 1: Telcagepant 300 mg soft gel capsules intervention 2: Telcagepant 280 mg tablets intervention 3: Rizatriptan 10 mg tablets intervention 4: Placebo to telcagepant capsules intervention 5: Placebo to telcagepant tablets intervention 6: Placebo to rizatriptan tablets

0

null

0

NCT00443209

[ 0 ]

1,496

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with the currently approved AD medication, Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects their response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-2)

Alzheimer's Disease

apolipoprotein E Alzheimer's disease cognition rosiglitazone adjunctive therapy

null

3

arm 1: Rosiglitazone Extended Release 2mg OD arm 2: Rosiglitazone Extended Release 8mg OD arm 3: Placebo

[ 0, 0, 2 ]

4

[ 0, 0, 10, 10 ]

intervention 1: Rosiglitazone Extended Release 2mg OD intervention 2: Rosiglitazone Extended Release 8mg OD intervention 3: Placebo intervention 4: Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).

intervention 1: Rosiglitazone Extended Release 2mg intervention 2: Rosiglitazone Extended Release 8mg intervention 3: Placebo intervention 4: Donepezil

249

1

NCT00348309

[ 3 ]

63

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.

OBJECTIVES: I. Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate. II. Determine the objective response rate of patients treated with this drug. III. Determine the safety of this drug in these patients. OUTLINE: Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Gastrointestinal Stromal Tumor

null

1

arm 1: Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

[ 0 ]

2

[ 3, 0 ]

intervention 1: Undergo surgical resection intervention 2: Given orally

intervention 1: Conventional Surgery intervention 2: Imatinib Mesylate

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00028002

[ 3, 4 ]

64

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

Adrenal insufficiency is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving replacement therapy with hydrocortisone or cortisone acetate have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease and premature mortality that is more than twice the mortality rate in the background population. Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur. In this trial a newly developed novel dual-, controlled release formulation of hydrocortisone that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary adrenal insufficiency (Addison's disease).

Adrenal Insufficiency

Adrenal insufficiency Primary adrenal insufficiency Addison's disease Hydrocortisone Modified release

null

2

arm 1: Test drug: hydrocortisone (modified release), oral tablet, available as 20 mg and 5 mg. The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state arm 2: Reference drug: hydrocortisone, oral tablet, 10 mg. The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM)in the same total daily dose as the experimental drug. The morning dose was administered in the fasting state.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial intervention 2: The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered in the fasting state. The total daily dose was the same as in the experimental treatment arm.

intervention 1: hydrocortisone (modified release), oral tablet 20 and 5 mg intervention 2: Hydrocortisone, oral tablet, 10 mg

0

null

0

NCT00915343

[ 3 ]

53

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

2MALE

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 24 hours after herniorrhaphy.

Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges. Bupivacaine is a local anesthetic (pain medicine) 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 cow 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. This study will compare the amount of narcotic pain medication required after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Postoperative Pain Inguinal Hernia

Herniorrhaphy Inguinal Hernia Repair Postoperative pain

null

2

arm 1: Two, 5x5cm bupivacaine collagen sponges implanted during surgery arm 2: Placebo collagen sponge implanted during surgery

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: collagen; Bupivacaine hydrocholoride intervention 2: collagen

intervention 1: Bupivacaine Collagen Sponge intervention 2: placebo collagen sponge

1

Anaheim | California | United States | -117.9145 | 33.83529

0

NCT00626886

[ 3 ]

401

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.

Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender. Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet. Participants will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each participant will be encouraged to adhere to medication and dietary instructions.

Obesity Overweight Body Weight

null

2

arm 1: SCH 497079, administered orally, once daily arm 2: Placebo capsules, administered orally, once daily

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 100 mg capsule administered orally intervention 2: Placebo capsules matching SCH 497079 administered orally

intervention 1: SCH 497079 intervention 2: Placebo

0

null

0

NCT00642993

[ 3 ]

15

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Critically injured patients endure a period of hypermetabolism/catabolism after being resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor wound healing, susceptibility to infection and long hospital stays. While there have been some data to suggest that hypermetabolism can be ameliorated in burn patients by beta blockade, to our knowledge, a prospective trial in trauma patients has not yet been done. Our hypothesis is that nonselective beta blockade will reduce catabolism, improve glucose control, blunt loss of lean body mass, decrease infections and improve outcome in a cohort of critically injured patients.

null

Trauma

null

2

arm 1: None arm 2: None

[ 0, 4 ]

1

[ 0 ]

intervention 1: None

intervention 1: Propranolol

1

Denver | Colorado | United States | -104.9847 | 39.73915

0

NCT00356187

[ 3 ]

333

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.

Rapid progression of liver disease to liver failure has been observed in people coinfected with HIV and HCV. This observation appears to be directly related to an increase in the rate of fibrotic progression in the liver compared to people infected with HCV alone. PEG-IFN and ribavirin are used in standard treatment of HCV. This study tested the effectiveness of using PEG-IFN in reducing the rate of liver fibrosis progression in participants coinfected with HIV and HCV who could not lower their HCV viral load to undetectable or who could not maintain their HCV viral load at undetectable on PEG-IFN and ribavirin treatment. Participants entered Step 1 (initial run-in period) to receive 12 weeks of 180 mcg PEG-IFN subcutaneously once weekly plus 1 to 1.2 g/day ribavirin based on body weight. At week 12, HCV RNA testing was performed. Participants with early virologic response (EVR), defined as \>=2 log10 drop in HCV RNA from baseline or undetectable HCV RNA (\<600 IU/ml with quantitative assay used in Step 1) at Week 12, who had tolerated Step 1 treatment, entered into Step 3 to continue receiving the Step 1 treatment for a total of 72 weeks (Arm C). Participants who did not meet the criteria for entry into Step 3 were discontinued from the study. In Step 3, participants were followed for an additional 24 weeks after treatment discontinuation to determine sustained virologic response (SVR). Initially, Step 3 participants who had a detectable HCV viral load (\>=60 IU/ml with the qualitative assay used in Step 3) at Week 36 were eligible to enroll in Step 2. After early closure of Step 2, such participants remained in Step 3 until study completion. Participants with \<2 log10 drop in HCV RNA from baseline and detectable HCV RNA at Week 12 (non-EVR) discontinued Step 1 treatment. Non-EVRs who met the Step 2 eligibility criteria, were enrolled in Step 2 and randomized to receive 180 mcg PEG-IFN subcutaneously weekly for 72 weeks (Arm A) or observation for 72 weeks (Arm B). Participants who did not meet the criteria for entry into Step 2 were discontinued from the study. Step 2 of the study was closed prematurely in May 2007 due to lower than expected progression rates among the participants in the observation arm such that the primary objective could not be reached. There were no safety concerns. Liver biopsies were conducted at study screening, and at Step 2 entry and exit until the early closure of Step 2. Medical history assessment, physical exams, and blood collection were conducted every 4-12 weeks for participants in Steps 1, 2, and 3. Participants were followed for up to 18 weeks in Step 1, followed by a total of 72 in Step 2 or by up to a total of 84 weeks in Step 3.

HIV Infections Hepatitis C Liver Disease

Treatment Experienced

null

3

arm 1: At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks. arm 2: At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment). arm 3: At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: 180 mcg PEG-IFN subcutaneously intervention 2: One tablet or capsule containing ribavirin 200 mg

intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin

37

1

NCT00078403

[ 4 ]

3,182

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)

null

Obesity

Obesity Weight loss lorcaserin APD356 BLOOM Hypertension Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena

null

2

arm 1: Lorcaserin 10 mg tablet each morning and evening arm 2: Matching placebo tablet each morning and evening

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks. intervention 2: Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.

intervention 1: Lorcaserin 10 mg BID intervention 2: Matching Placebo BID

1

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

0

NCT00395135

[ 4 ]

807

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.

Depressive Disorder, Major

major depressive disorder MDD depression

null

4

arm 1: DVS SR 50mg/day arm 2: DVS SR 100mg/day arm 3: DVS SR 200mg/day arm 4: Paroxetine 20mg/day

[ 0, 0, 0, 1 ]

2

[ 0, 0 ]

intervention 1: Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper intervention 2: 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

intervention 1: DVS SR intervention 2: Paroxetine

43

Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Guangdong Province | N/A | China | N/A | N/A Hunan Province | N/A | China | N/A | N/A Jiangsu Province | N/A | China | N/A | N/A Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shanxi Province | N/A | China | N/A | N/A Sichuan Province | N/A | China | N/A | N/A Yunnan Province | N/A | China | N/A | N/A Zhejiang Province | N/A | China | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Chandigarh | N/A | India | 76.7884 | 30.73629 Gujarat | N/A | India | N/A | N/A Gujarat | N/A | India | N/A | N/A Karnataka | N/A | India | N/A | N/A Karnataka | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Mumbai Maharashtra | N/A | India | N/A | N/A New Delhi | N/A | India | 77.2148 | 28.62137 Punjab | N/A | India | N/A | N/A Uttar Pradesh | N/A | India | N/A | N/A Incheon | N/A | South Korea | 126.70515 | 37.45646 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 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 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Chang-hua | N/A | Taiwan | 120.56276 | 24.07327 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306

1

NCT00445679

[ 3 ]

125

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.

null

Sleep Apnea, Obstructive Hypopnea Syndrome Excessive Daytime Sleepiness

null

6

arm 1: Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil arm 2: Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249 arm 3: Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo arm 4: Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo arm 5: Arm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil arm 6: Arm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249

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

3

[ 0, 0, 0 ]

intervention 1: Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd). intervention 2: Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd. intervention 3: Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.

intervention 1: Comparator: MK0249 intervention 2: Comparator: placebo intervention 3: Comparator: modafinil

0

null

1

NCT00620659

[ 4 ]

781

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Participants in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks. Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Participants who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.

Generalized Anxiety Disorder

Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy

null

5

arm 1: Placebo-matching capsules, orally, once daily for up to 9 weeks. arm 2: Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 3: Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 4: Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 5: Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.

[ 2, 0, 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Placebo-matching capsules intervention 2: Encapsulated vortioxetine immediate release tablets intervention 3: Overencapsulated duloxetine capsules

intervention 1: Placebo intervention 2: Vortioxetine intervention 3: Duloxetine

66

1

NCT00730691

[ 4 ]

271

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

null

Urinary Tract Infection

null

2

arm 1: ertapenem sodium arm 2: ceftriaxone sodium

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed) intervention 2: a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)

intervention 1: ertapenem sodium (MK0826) intervention 2: Comparator: ceftriaxone sodium

0

null

1

NCT01014013