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

[ 5 ]

360

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.

A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105927)

Rhinitis, Allergic, Perennial

experience GW685698X fluticasone furoate preference seasonal allergic rhinitis fluticasone propionate

null

4

arm 1: fluticasone furoate nasal spray, fluticasone propionate nasal spray arm 2: fluticasone propionate nasal spray, fluticasone furoate nasal spray arm 3: placebo nasal spray matching fluticasone furoate nasal spray, placebo nasal spray matching fluticasone propionate nasal spray arm 4: placebo nasal spray matching fluticasone propionate nasal spray, placebo nasal spray matching fluticasone furoate nasal spray

[ 1, 1, 2, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: fluticasone propionate nasal spray intervention 2: fluticasone furoate nasal spray intervention 3: placebo nasal spray matching fluticasone furoate nasal spray intervention 4: placebo nasal spray matching fluticasone propionate nasal spray

intervention 1: FPNS intervention 2: FFNS intervention 3: placebo FFNS intervention 4: placebo FPNS

28

0

NCT00519636

[ 5 ]

377

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

null

The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.

A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105924)

Rhinitis, Allergic, Perennial

fluticasone propionate seasonal allergic rhinitis fluticasone furoate experience GW685698X preference

null

4

arm 1: active compound arm 2: active compound arm 3: placebo arm arm 4: placebo arm

[ 1, 1, 2, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: fluticasone propionate nasal spray intervention 2: fluticasone furoate nasal spray intervention 3: placebo nasal spray matching fluticasone propionate nasal spray intervention 4: placebo nasal spray matching fluticasone furoate nasal spray

intervention 1: FPNS intervention 2: FFNS intervention 3: placebo FPNS intervention 4: placebo FFNS

24

0

NCT00539006

[ 5 ]

86

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

null

This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.

null

Attention Deficit Hyperactivity Disorder

ADHD children laboratory classroom Attention Deficit Hyperactivity Disorder

null

2

arm 1: 20 mg capsule orally once a day for 7 days arm 2: orally once a day for 7 days

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 20 mg capsule orally once a day for 7 days intervention 2: orally once a day for 7 days

intervention 1: Dex-methylphenidate hydrochloride extended-release (Focalin XR) intervention 2: Placebo

5

0

NCT00564954

[ 3 ]

56

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.

To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test). Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life. Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).

Heart Failure Growth Hormone Deficiency Ischemic Heart Disease

Heart Failure Growth Hormone Anabolism Anabolic Deficiency Hormone replacement

null

2

arm 1: Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0.012 mg/kg every second day, added to their background optimized CHF therapy arm 2: PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

[ 0, 4 ]

1

[ 0 ]

intervention 1: Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months

intervention 1: Somatotropin

0

null

0

NCT00591760

[ 2, 3 ]

36

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

2DOUBLE

false

0ALL

false

This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at baseline and subjects will be observed for up to 26 weeks following the infusion.

null

Plaque Psoriasis

Plaque psoriasis

null

2

arm 1: AIN457A 3mg/kg was administered intravenously as a single dose. arm 2: Placebo was administered intravenously as a single dose.

[ 0, 2 ]

2

[ 2, 0 ]

intervention 1: single infusion of 3 mg/kg intervention 2: single infusion of placebo

intervention 1: AIN457 intervention 2: Placebo

0

null

0

NCT00669916

[ 4 ]

481

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

false

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

null

Seasonal Allergic Rhinitis

null

2

arm 1: 0mg Placebo Nasal Spray arm 2: 0.15% azelastine hydrochloride

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Placebo intervention 2: 0.15% azelastine hydrochloride 822 mcg

intervention 1: Placebo nasal spray intervention 2: 0.15% azelastine hydrochloride Nasal Spray

34

0

NCT00719862

[ 4 ]

526

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study was to determine if two allergy medications are more effective than placebo.

null

Seasonal Allergic Rhinitis

null

3

arm 1: Placebo nasal spray arm 2: 0.1% azelastine hydrochloride nasal spray arm 3: 0.15% azelastine hydrochloride nasal spray

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 0.15% azelastine hydrochloride 1644 mcg daily intervention 2: 0.1% azelastine hydrochloride 1096 mcg daily intervention 3: 0 mcg Placebo daily

intervention 1: 0.15% azelastine hydrochloride 1644 mcg daily intervention 2: 0.1% azelastine hydrochloride 1096 mcg daily intervention 3: Placebo

29

0

NCT00720278

[ 4 ]

29

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

Dental Plaque

null

4

arm 1: Fluoride only toothpaste arm 2: Triclosan/fluoride toothpaste arm 3: toothpaste containing amino acid #1 arm 4: toothpaste containing amino acid/bicarbonate

[ 2, 1, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Brush two times a day for 4 days. intervention 2: Brush two times daily for 4 days intervention 3: Brush twice daily for 4 days intervention 4: Brush twice daily for 4 days

intervention 1: Fluoride intervention 2: Triclosan/Fluoride intervention 3: Triclosan/Fluoride intervention 4: Triclosan/Fluoride

1

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

0

NCT00758394

[ 4 ]

412

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).

This two-arm, multicentre, randomized, placebo-controlled, double-blind, parallel-design study consisted of a baseline phase (screening and wash-out) and a double-blind randomized phase (randomization to Trazodone Contramid® OAD or placebo). The total study duration including wash-out of prohibited medications was approximately 11 weeks; the total duration of the randomized phase was 8 weeks (titration: 2 weeks + treatment: 6 weeks).

Major Depressive Disorder

Unipolar

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Trazodone Hydrochloride (HCl) Extended-Release Tablets intervention 2: Placebo

36

0

NCT00775203

[ 0 ]

90

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?

Patients are contacted pre-operatively and their parents consented. The following criteria apply: Inclusion criteria: All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital Exclusion Criteria: Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first. Thrombosis is demonstrated by echocardiogram or ultrasound performed at 1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug. The following are calculations for statistical analysis: Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.

Thrombosis

null

2

arm 1: Heparin sulfate infusion at 10 units/kg/hour arm 2: Placebo - normal saline infusion

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery intervention 2: Infusion of normal saline

intervention 1: Heparin sulfate infusion at 10 units/kg/hour intervention 2: Placebo infusion

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00779558

[ 2 ]

54

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated.

Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Additionally, the safety and tolerability of this dosing regimen will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of two dosing regimens (fenofibric acid and fenofibrate) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet) 30 minutes after the initiation of a standard breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen 30 minutes after the initiation of a standard breakfast. Fasting will continue for 4 hours after each dose. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours post-dose. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form.

Healthy

healthy pharmacokinetics therapeutic equivalency

null

2

arm 1: 1 x 105 mg fenofibric acid (Fibricor™)tablet administered 30 minutes after the initiation of a standard breakfast. arm 2: 1 x 145 mg fenofibrate (Tricor®) tablet administered 30 minutes after the initiation of a standard breakfast.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 1 x 105 mg fenofibric acid (Fibricor™) tablet administered 30 minutes after the initiation of a standard breakfast. intervention 2: 1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.

intervention 1: Fenofibric Acid (Fibricor™) 105 mg Tablet intervention 2: Fenofibrate (Tricor®) 145 mg Tablet

0

null

0

NCT00960687

[ 2 ]

40

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will be evaluated.

The primary objective of this study is to determine the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions each separated by a 7 day washout period. On study Days 1, 8, 15 and 22 each subject will receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal according to their randomization sequence. Subjects will fast for at least 4.25 hours after dosing in each of the four dosing conditions. Blood samples will be drawn from all participants before dosing and for 72 hours post-dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Seated blood pressure and heart rate will be measured prior to dosing and at 2 hours post-dose. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Healthy

pharmacokinetics

null

4

arm 1: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast. arm 2: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast. arm 3: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast. arm 4: Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast. intervention 2: One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast intervention 3: One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast. intervention 4: One 105 mg tablet administered after an overnight fast of at least 10 hours.

intervention 1: Fenofibric Acid 105 mg Tablet intervention 2: Fenofibric Acid 105 mg Tablet intervention 3: Fenofibric Acid 105 mg Tablet intervention 4: Fenofibric Acid 105 mg Tablet

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT00960856

[ 4 ]

67

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation

null

Dental Plaque

null

2

arm 1: control mouthrinse arm 2: new prototype mouthrinse

[ 2, 0 ]

2

[ 0, 10 ]

intervention 1: Rinse 2 times per day for 6 weeks intervention 2: Use 2 times per day for 6 weeks

intervention 1: Iodine intervention 2: water

1

Northfield | New Jersey | United States | -74.55015 | 39.37039

0

NCT01021007

[ 2 ]

79

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed 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 80 mg x 1 dose arm 2: Original OxyContin® (OXY) 80 mg x 1 dose

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Reformulated OXY 80-mg tablet x 1 dose taken with food. intervention 2: Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.

intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT01101178

[ 3 ]

130

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.

This study was a multicenter, randomized, double blind, active and placebo controlled, parallel group study. Eligible subjects were randomized in a 1:1:1:1 ratio to 1 of the following 4 treatment groups: A) XP13512 Placebo + Diphenhydramine Placebo (Pbo) B) XP13512 1200 mg/day + Diphenhydramine Placebo (1200 mg) C) XP13512 1800 mg/day + Diphenhydramine Placebo (1800 mg) D) XP13512 Placebo + 50 mg Diphenhydramine (Pbo/DPH)

Restless Legs Syndrome

null

4

arm 1: XP13512 Placebo + Diphenhydramine Placebo arm 2: XP13512 1200 mg/day + Diphenhydramine Placebo arm 3: XP13512 1800 mg/day + Diphenhydramine Placebo arm 4: XP13512 Placebo + 50 mg Diphenhydramine

[ 2, 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: XP13512 once daily for 16 days intervention 2: one 50 mg dose of diphenhydramine (DPH) on day 16 intervention 3: XP13512 placebo once daily for 16 days

intervention 1: XP13512 intervention 2: Diphenhydramine intervention 3: Placebo

1

Albuquerque | New Mexico | United States | -106.65114 | 35.08449

0

NCT01332318

[ 2 ]

48

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

0ALL

null

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.

null

Diabetes Mellitus, Type 2

null

4

arm 1: multiple doses as tablet arm 2: multiple doses as tablet arm 3: multiple doses as tablet arm 4: multiple doses as tablet

[ 0, 0, 0, 0 ]

8

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

intervention 1: po taken fasting with 240 mL water intervention 2: po taken fasting with 240 mL water intervention 3: po taken fasting with 240 mL water intervention 4: po taken fasting with 240 mL water intervention 5: po taken fasting with 240 mL water intervention 6: po taken fasting with 240 mL water intervention 7: po taken fasting with 240 mL water intervention 8: po taken fasting with 240 mL water

intervention 1: BI 10773 Placebo intervention 2: BI 10773 intervention 3: BI 10773 Placebo intervention 4: BI 10773 intervention 5: BI 10773 Placebo intervention 6: BI 10773 Placebo intervention 7: BI 10773 intervention 8: BI 10773

1

Neuss | N/A | Germany | 6.68504 | 51.19807

0

NCT01924767

[ 2 ]

26

NA

SINGLE_GROUP

0TREATMENT

1SINGLE

true

0ALL

false

Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.

Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers. A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg each given QD. The single dose was chosen to assess the ESL acute response relationship with respect to cognitive and motor skill performance, and the multiple doses were chosen to further characterize the ESL dose response relationship with respect to cognitive and motor skill performance.

Epilepsy

null

1

arm 1: A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: BIA 2-093

0

null

0

NCT02284828

[ 3 ]

24

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD.

A randomised, double blind, placebo-controlled, double dummy, 4-way cross-over, dose ascending study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK573719 (3 escalating mcg doses will be used) and tiotropium bromide (18µg) via DPI in COPD patients

Pulmonary Disease, Chronic Obstructive

chronic obstructive pulmonary disease, GSK573719, muscarinic receptor antagonist

null

12

arm 1: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days. arm 2: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days. arm 3: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 4: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, placebo and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 5: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 6: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 7: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, Tiotropium 18 µg, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 8: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, placebo, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 9: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days. arm 10: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, placebo and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 11: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days. arm 12: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and Tiotropium 18 µg. Treatment periods were seperated by a washout period of at least 14 days.

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

2

[ 0, 0 ]

intervention 1: 250 micrograms (μg) per blister, administered via dry powder inhaler, dose-ascending study doses began at 250 ug, then 500 ug, and 1000 μg intervention 2: strips of five capsules, each containing 18 μg administered via dry powder inhaler

intervention 1: GSK573719 intervention 2: Tiotropium

3

Hanover | Lower Saxony | Germany | 9.73322 | 52.37052 Berlin | N/A | Germany | 13.41053 | 52.52437 Hamburg | N/A | Germany | 9.99302 | 53.55073

0

NCT00515502

[ 2 ]

26

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

null

The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.

null

Hypercholesterolemia

null

4

arm 1: ER niacin/laropiprant + Placebo to laropiprant arm 2: ER niacin + Placebo to laropiprant arm 3: laropiprant + Placebo to ER niacin/laropiprant arm 4: Placebo

[ 0, 1, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days intervention 2: ER niacin 2 g tablet once daily for 7 days intervention 3: laropiprant 40 mg once daily for 7 days intervention 4: matching placebo tablets for each of the interventions once daily for 7 days

intervention 1: Comparator: niacin + laropiprant intervention 2: Comparator: niacin intervention 3: Comparator: laropiprant intervention 4: Comparator: placebo

0

null

0

NCT00769132

[ 3 ]

90

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.

null

Cerebral Infarction

null

3

arm 1: Vorapaxar oral tablets; once daily for 60 days + Aspirin. arm 2: Vorapaxar oral tablets; once daily for 60 days + Aspirin. arm 3: Placebo oral tablets; once daily for 60 days + Aspirin

[ 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Oral tablets; once daily for 60 days. intervention 2: Oral tablets; once daily for 60 days intervention 3: oral tablets; once daily for 60 days intervention 4: oral tablets; once daily for 60 days

intervention 1: Vorapaxar 2.5 mg intervention 2: Vorapaxar 1 mg intervention 3: Placebo intervention 4: Aspirin 75-150 mg

0

null

0

NCT00684515

[ 4 ]

269

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.

null

Pharyngitis

sore throat acute pain

null

4

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

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg intervention 2: dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo intervention 3: dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg intervention 4: dose 1 placebo followed 6-12 hours later by dose 2 placebo

intervention 1: Celecoxib intervention 2: Celecoxib intervention 3: celecoxib intervention 4: placebo

1

Storrs | Connecticut | United States | -72.24952 | 41.80843

0

NCT00402987

[ 4 ]

397

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for Assisted Reproductive Technology (ART). For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two treatment groups in the number of oocytes retrieved is the primary objective of this trial.

Infertility

In vitro fertilization Pharmacological effects of drugs Hormones Hormone Substitutes and Hormone Antagonists Pharmacological Actions Randomized Multi-center Multi-national Double-blind Active-controlled Equivalence

null

2

arm 1: Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses. arm 2: Participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

[ 0, 1 ]

8

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

intervention 1: 100 µg corifollitropin alfa subcutaneous (SC) injection intervention 2: 150 IU recFSH SC injection intervention 3: GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day intervention 4: hCG 5,000 IU or 10,000 IU administered SC intervention 5: Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM. intervention 6: Placebo-recFSH administered at the equivalent volume of 150 IU/day. intervention 7: Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle. intervention 8: Open-label recFSH administered up to a maximum dose of 200 IU/day.

intervention 1: corifollitropin alfa (Org 36286) intervention 2: recFSH (follitropin beta) intervention 3: gonadatropin releasing hormone (GnRH) antagonist (ganirelix) intervention 4: human chorion gonadatropin (hCG) intervention 5: progesterone intervention 6: placebo-recFSH (follitropin alfa) intervention 7: placebo-corifollitropin alfa intervention 8: open-label recFSH

0

null

0

NCT00702845

[ 4 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

null

Rheumatoid Arthritis

null

1

arm 1: None

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: 1000 mg iv Days 1 and 15 intervention 2: 10 - 25 mg/week intervention 3: iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

intervention 1: rituximab [MabThera/Rituxan] intervention 2: methotrexate intervention 3: methylprednisolone

3

Belgrade | N/A | Serbia | 20.46513 | 44.80401 Niška Banja | N/A | Serbia | 22.0057 | 43.29507 Nova Sad | N/A | Serbia | N/A | N/A

0

NCT02006706

[ 3 ]

31

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.

Other objectives of this study are to assess the safety, tumor response, time to disease progression, survival rate and to explore several potential biomarkers to see how these levels change after administration of SNS-595.

Carcinoma, Non-Small-Cell Lung

Lung Squamous Cell Large Cell Adenocarcinoma Carcinoma Cancer

null

1

arm 1: Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)

[ 0 ]

1

[ 0 ]

intervention 1: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.

intervention 1: SNS-595 Injection

4

0

NCT00252382

[ 4 ]

559

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.

RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a randomized (patients are assigned different treatments based on chance), double-blind, (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) placebo-controlled study to explore the safety and effectiveness of RISPERDAL CONSTA in the prevention of mood episodes in patients with bipolar 1 disorder. This study includes 5 periods: a screening period lasting up to 1 week; an open-label RISPERDAL (oral risperidone) treatment period lasting 3 weeks; an open-label RISPERDAL CONSTA stabilization period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label extension with RISPERDAL CONSTA lasting 8 weeks. Efficacy will be assessed using the Young Mania Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions - Severity (CGI-S) scale, Medical Outcomes Study Short Form 36 (SF-36), and the Personal and Social Performance (PSP) scale. Safety will be evaluated throughout the study and includes assessment of adverse events, clinical laboratory tests (including hematology, serum chemistry, blood glucose/lipid profile, prolactin, and urinalysis); electrocardiograms (ECGs), vital signs (pulse and blood pressure), physical examination, body mass index (BMI), and the Extrapyramidal Symptom Rating Scale (ESRS). Oral risperidone (flexible dosage) 1 to 6 mg/day for the first 3 weeks. Risperidone LAI i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50 mg) given every 2 weeks for up to approximately 2.6 years (only 6 months for patients receiving placebo during DB-period)

Bipolar Disorder

Mood episodes Bipolar 1 disorder Intramuscular Injectable risperidone safety and efficacy

null

2

arm 1: Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks arm 2: Placebo Matching placebo intramuscular (IM) injection every 2 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks intervention 2: Matching placebo intramuscular (IM) injection every 2 weeks

intervention 1: Risperdal Consta intervention 2: Placebo

51

Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Mesa | California | United States | -117.02308 | 32.76783 National City | California | United States | -117.0992 | 32.67811 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Bradenton | Florida | United States | -82.57482 | 27.49893 Hialeah | Florida | United States | -80.27811 | 25.8576 Lake Charles | Louisiana | United States | -93.2044 | 30.21309 Towson | Maryland | United States | -76.60191 | 39.4015 Clementon | New Jersey | United States | -74.98294 | 39.8115 Lyndhurst | Ohio | United States | -81.48873 | 41.52005 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 DeSoto | Texas | United States | -96.85695 | 32.58986 Richmond | Virginia | United States | -77.46026 | 37.55376 Neunkirchen | N/A | Austria | 16.08107 | 47.72096 Bangalore | N/A | India | 77.59369 | 12.97194 Hyderabad | N/A | India | 78.45636 | 17.38405 Manipal | N/A | India | 74.78333 | 13.35 Johor Bahru | N/A | Malaysia | 103.7578 | 1.4655 Kota Bharu | N/A | Malaysia | 102.24333 | 6.12361 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Choroszcz | N/A | Poland | 22.98889 | 53.14332 Gdansk | N/A | Poland | 18.64912 | 54.35227 Swiecie Poland | N/A | Poland | N/A | N/A Tuszyn | N/A | Poland | 19.53009 | 51.60949 Lipetsk | N/A | Russia | 39.57076 | 52.60311 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow Region | N/A | Russia | N/A | N/A Moscow Russia | N/A | Russia | N/A | N/A Nizny Novgorod | N/A | Russia | N/A | N/A Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Samara | N/A | Russia | 50.15 | 53.20007 Saratov | N/A | Russia | 46.00861 | 51.54056 St-Petresburg | N/A | Russia | N/A | N/A Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Rimavská Sobota | N/A | Slovakia | 20.02239 | 48.38284 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 Dnipro | N/A | Ukraine | 35.04066 | 48.46664 Hlevakha | N/A | Ukraine | 30.32706 | 50.27423 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Simferopol | N/A | Ukraine | 34.11079 | 44.95719 Vinnitsa | N/A | Ukraine | 37.71861 | 49.84639

1

NCT00132678

[ 4 ]

77

NON_RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.

null

Bipolar Disorder

null

2

arm 1: Asenapine arm 2: Placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks intervention 2: Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks

intervention 1: Asenapine intervention 2: Placebo

0

null

1

NCT00145509

[ 4 ]

154

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

true

A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.

A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry. Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety of this treatment. Core study completion criteria (protocol final height) are that the patient has both a height velocity \< 2 cm per year and a bone age of 14 years or greater. Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19, 1997. Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the Core study. Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.

Turner Syndrome

syndrome Turner Turner's height growth growth hormone somatropin short stature short hearing glucose metabolism

null

2

arm 1: Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). arm 2: Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).

[ 4, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height). intervention 2: escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met. intervention 3: 10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.

intervention 1: Somatropin intervention 2: Ethinyl estradiol intervention 3: Medroxyprogesterone acetate

14

1

NCT00191113

[ 4 ]

381

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.

null

Schizophrenia Bipolar I Disorder

null

0

null

1

[ 0 ]

intervention 1: Oral dosing, flexible dosing

intervention 1: quetiapine fumarate

48

1

NCT00227305

[ 4 ]

280

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Tumor Lysis Syndrome Cancer Hyperuricemia

Hyperuricemia Tumor lysis syndrome Leukemia Lymphoma Myelodysplastic Syndromes Solid tumor cancers Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only) Tumor lysis syndrome (cancer patients only)

null

3

arm 1: Rasburicase alone given as a single agent for 5 days arm 2: Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap) arm 3: Oral allopurinol alone given as a single agent for 5 days

[ 0, 0, 1 ]

2

[ 0, 0 ]

intervention 1: 30-min IV infusion intervention 2: Oral administration

intervention 1: Rasburicase (SR29142) intervention 2: Allopurinol

15

1

NCT00230178

[ 4 ]

260

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Anemia

null

2

arm 1: 120-360 micrograms (iv) monthly, starting dose arm 2: As prescribed, (iv), 3 times weekly

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 120-360 micrograms intravenous (iv) monthly, starting dose intervention 2: As prescribed, iv, 3 times weekly

intervention 1: methoxy polyethylene glycol-epoetin beta intervention 2: Epoetin alfa

44

1

NCT00422513

[ 4 ]

680

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Bacterial Infections

Abscess Antibacterial Antibiotic Antimicrobial Bacterial infection, skin Ceftaroline Ceftaroline acetate Cellulitis Cephalosporin Complicated skin and skin structure infection (cSSSI) cSSSI Intravenous Methicillin-resistant Staphylococcus Aureus (MRSA) PPI-0903 Prodrug Skin disease, bacterial Skin infection Staphylococcal skin infection Staphylococcus aureus Streptococcal skin infection Surgical site infection TAK-599

null

2

arm 1: Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. arm 2: Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days intervention 2: vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. intervention 3: Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

intervention 1: ceftaroline intervention 2: vancomycin plus aztreonam intervention 3: Placebo

54

Buena Park | California | United States | -117.99812 | 33.86751 Hawaiian Gardens | California | United States | -118.07284 | 33.8314 Los Angeles | California | United States | -118.24368 | 34.05223 Pasadena | California | United States | -118.14452 | 34.14778 San Diego | California | United States | -117.16472 | 32.71571 San Jose | California | United States | -121.89496 | 37.33939 Atlantis | Florida | United States | -80.10088 | 26.5909 Columbus | Georgia | United States | -84.98771 | 32.46098 Marietta | Georgia | United States | -84.54993 | 33.9526 Springfield | Illinois | United States | -89.64371 | 39.80172 Baltimore | Maryland | United States | -76.61219 | 39.29038 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Butte | Montana | United States | -112.53474 | 46.00382 Somers Point | New Jersey | United States | -74.5946 | 39.31762 Toledo | Ohio | United States | -83.55521 | 41.66394 Tacoma | Washington | United States | -122.44429 | 47.25288 Milwaukee | Wisconsin | United States | -87.90647 | 43.0389 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Córdoba | N/A | Argentina | -64.18853 | -31.40648 Santa Fe | N/A | Argentina | -60.70868 | -31.64881 Braunau am Inn | N/A | Austria | 13.04343 | 48.25628 Graz | N/A | Austria | 15.45 | 47.06667 Sankt Pölten | N/A | Austria | 15.63333 | 48.2 Sao Paula | N/A | Brazil | N/A | N/A Temuco | N/A | Chile | -72.59738 | -38.73628 Valdivia | N/A | Chile | -73.24589 | -39.81422 Cottbus | N/A | Germany | 14.32888 | 51.75769 Dortmund | N/A | Germany | 7.466 | 51.51494 Homburg/Saar | N/A | Germany | N/A | N/A Mainz | N/A | Germany | 8.2791 | 49.98419 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Riga | N/A | Latvia | 24.10589 | 56.946 Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738 Seattle Zapopan | Jalisco | Mexico | N/A | N/A Bielsko-Biala | N/A | Poland | 19.04686 | 49.82245 Krakow | N/A | Poland | 19.93658 | 50.06143 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Poznan | N/A | Poland | 16.92993 | 52.40692 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow Region | N/A | Russia | N/A | N/A Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Zaporizhya | N/A | Ukraine | N/A | N/A London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853

1

NCT00423657

[ 3 ]

12

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will test the safety and effectiveness of two drugs, Sirolimus and Thymoglobulin, for preventing rejection of transplanted kidneys. Standard anti-rejection therapy uses a combination of drugs, such as cyclosporine, tacrolimus, azathioprine, steroids, and others, that are taken daily for life. However, even with this daily therapy, more than half of kidney recipients slowly reject their transplant within 10 years. Both Thymoglobulin, an antibody, and Sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. Thymoglobulin is given in the pre- and postoperative period, and Sirolimus is taken long term. Patients who receive a kidney transplant at the National Institutes of Health Clinical Center are eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests. Participants will undergo a kidney transplant. Before the surgery, a central line (intravenous catheter), through which blood and medicine can be given, is placed in the neck or chest. Patients may also undergo leukapheresis, a procedure for collecting white blood cells. The cells can be stored for transfusion later if white cell counts drop following Thymoglobulin treatment. For this procedure, blood is drawn from a needle placed in the arm and flows into a machine that separates the blood components by spinning. The white cells are collected in a bag and the red cells and plasma are returned through a second needle in the other arm. Thymoglobulin will be given intravenously the day before the transplant and days 1 through 9 after the operation. Sirolimus will be taken by mouth, mixed with water or orange juice. Sirolimus therapy starts the day of the transplant and continues for life. Follow-up study visits will be scheduled weekly for the first month after the transplant, then every 6 months for 1 year and then once a year for 4 years. Procedures during these visits may include blood and urine tests, physical examination, and check of vital signs (i.e., blood pressure, heart rate, breathing rate, temperature). Kidney biopsies (removal of a small piece of tissue for examination under the microscope) will be done at 2 weeks, 1 month and 6 months after surgery and then yearly for 4 years to check for any damage to the kidney. In addition, a local doctor will do routine laboratory tests 2 to 3 times a week for the first 2 to 3 months aft...

This protocol will test a novel dual agent combination therapy for its ability to prevent human renal allograft rejection. Thymoglobulin (Sangstat), a FDA-approved polyclonal rabbit-IgG antithymocyte preparation, will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst), an oral immunosuppressant agent recently approved by the FDA. Rapamycin allows for antigen specific T cell activation but prevents T cell clonal expansion by interrupting IL-2 receptor beta-chain signal transduction. The rationale for this combination is to eliminate existing alloreactive T cell clones that could initiate a rejection at the time of transplantation, and to promote graft specific activation induced cell death (AICD) in repopulating T cells such that an allospecific T cell deficit is induced. The desired effect of this therapy is to prevent allograft rejection without the chronic use of calcineurin inhibitors or glucocorticosteroids, and in doing so, develop a regimen for transplantation that avoids most of the chronic drug toxicities inherent in the use of these two classes of immunosuppressants. Twenty people will be evaluated in this pilot protocol. Ten will receive living donor kidney allografts and ten will receive cadaveric kidney allografts. Patients will be treated with Thymoglobulin beginning prior to graft implantation and continuing for ten days. Glucocorticosteroids will be given during the Thymoglobulin treatment to limit monocyte activation and prevent the cytokine release syndrome associated with this antibody preparation. Patients will be given Sirolimus orally beginning the day after transplantation and continuously thereafter. Patients will then be monitored for evidence of allograft rejection using standard functional parameters and protocol allograft biopsies. In addition, patients will be followed for a specific desired effect, allospecific AICD, that should promote the development of allospecific graft tolerance. This will be accomplished by assaying peripheral blood and allograft biopsies for apoptosis and peripheral blood for evidence of alloreactive T cell clone depletion.

Kidney Failure

Renal Failure Anti-rejection Apoptosis Polyclonal Antibody Kidney Transplant

null

1

arm 1: Thymoglobulin (Sangstat), a FDA-approved polyclonal rabbit-IgG antithymocyte preparation, will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst), an oral immunosuppressant agent recently approved by the FDA.

[ 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Sirolimus intervention 2: Thymoglobulin

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00006178

[ 4 ]

330

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place at approximately 6-month intervals.

The objective of this trial was to determine whether IGF-1 (MyotrophinTM) slows progression of weakness in amyotrophic lateral sclerosis (ALS). Three hundred thirty patients with ALS from 20 medical centers participated in this double blind, placebo-controlled two-year study. Half the patients received IGF-1 and the other half received placebo. The drug will be administered twice a day. ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of motor neurons. IGF-1 is a neurotrophic factor essential for normal development of the nervous system and shows protection of motor neurons in animal models and cell culture systems. It is thought to block cell death pathways and promote muscle re-innervation and axonal growth and regeneration.

Amyotrophic Lateral Sclerosis

amyotrophic lateral sclerosis ALS progressive weakness insulin-like growth factor-1 IGF-I Myotrophin

null

2

arm 1: Insulin like growth factor, type 1 will be given 0.05 mg per kg body weight subcutaneously twice daily arm 2: Placebo arm

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 0.05 mg per kg body weight given subcutaneously twice daily intervention 2: The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.

intervention 1: Insulin like growth factor, type 1 intervention 2: Placebo

20

0

NCT00035815

[ 5 ]

65

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend in treatment is the addition of a second antipsychotic drug. This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy. Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. Neurological tests, self administered questionnaires, and interviews are used to assess patients.

Schizophrenia

null

2

arm 1: Participants assigned to risperidone arm 2: Participants assigned to placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Placebo capsule daily for 16 weeks intervention 2: Risperdal 4 mg per day for 16 weeks

intervention 1: Placebo intervention 2: Risperdal

1

Catonsville | Maryland | United States | -76.73192 | 39.27205

0

NCT00056498

[ 3 ]

148

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of ARV, and the effect on quality of life. The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients. But when used long term, those medications have been associated with great toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes, or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus to gain entry into its host. The CD4 count increases immediately in response to ARV, giving an estimate of the state of a patient's immune system. Thus, it is a strong marker of the immediate risk of an opportunistic infection, one that takes advantage of a person's weakened immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8 weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV. Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection, may be eligible for this study. Participants will undergo the following procedures and tests: * Physical examination. * Blood tests to measure blood lipids (fats), sugar, complete blood count including platelets, and chemistries. * Assessment of fat distribution. * Questionnaire about quality of life. In addition, those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24. They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter. The study will continue into 120 weeks. Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts. Every 24 weeks, they will be asked to answer a questionnaire about their quality of life. Blood tests and other measurements will also be done as follow-up.

The use of antiretroviral (ARV) medications has greatly improved morbidity and mortality of HIV-infected patients but long-term use of these agents has been associated with significant toxicities and medication fatigue that can lead to problems with adherence and eventual development of virologic resistance. The spectrum of ARV toxicities is broad including the development of lipodystrophy syndrome with lipid abnormalities and glucose intolerance or diabetes, while increasing evidence suggests an increased risk of cardiovascular complications in ARV-treated HIV-infected individuals. Current PHHS treatment guidelines recommend deferring ARV treatment initiation in asymptomatic HIV-infected individuals with CD4 count greater than or equal to 350 cells/micro liter, and treatment initiation after the CD4 count is less than 350 cells/micro liter. Several patients who started antiretroviral therapy at higher CD4 counts (based on older treatment initiation guidelines) or have experienced significant immunologic reconstitution after ARV initiation, elect to interrupt antiretroviral therapy until their CD4 count reaches the level of current recommendations for therapy initiation (less than 350 cells/micro liter). Studies to date suggest that baseline and nadir CD4 count are the best predictors of a longer duration of treatment interruption that may be more beneficial with respect to reversal or delay of long-term ARV-associated toxicity and improved quality of life. It is known that intermittent cycles of IL-2 administration can lead to expansion of the CD4 pool and prolong survival of CD4 T cells. In this study the hypothesis tested is that IL-2 given prior to ARV treatment interruption could significantly prolong the period of ARV treatment interruption with preservation of CD4 counts above 350 cells/micro liter, and that this prolongation will be beneficial with respect to antiretroviral related toxicity and quality of life. The study will have two parts: during the first part (24 weeks) patients will be randomized 1:1 to either receive three cycles or IL-2 with their ARV therapy or ARV therapy alone. In the second part (week 24 to week 120), all participants will interrupt therapy and restart when CD4 is less than 350 cells/micro liter. The main comparison will be at week 72, when the proportion of patients from the two groups who remain off drugs and have a CD4 greater than 350 cells/micro liter will be compared. At regular intervals (every 24 weeks) lipodystrophy measurements and quality of life questionnaires will be evaluated.

HIV Infections

Interleukin 2 Treatment Interruption HIV

null

2

arm 1: HAART (standard of care) and three cycles of IL-2 arm 2: HAART alone

[ 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Three cycles of IL-2 (6 MUI bid during 5 days = one cycle) intervention 2: HAART from week 0 to week 24 intervention 3: HAART is interrupted from week 24 in both arms

intervention 1: Interleukin 2 intervention 2: HAART intervention 3: Treatment interruption

2

Bethesda | Maryland | United States | -77.10026 | 38.98067 Créteil | N/A | France | 2.46569 | 48.79266

0

NCT00071890

[ 4 ]

74

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

null

Herpes Simplex

herpes simplex cold sores fever blisters children Famvir famciclovir

null

1

arm 1: single-arm

[ 0 ]

1

[ 0 ]

intervention 1: Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

intervention 1: Famciclovir

13

0

NCT00098059

[ 4 ]

298

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim is better than filgrastim alone in helping non-Hodgkin's lymphoma patients collect at least 5 million stem cells in four or less apheresis sessions. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Lymphoma, Non-Hodgkin

Non-Hodgkin's lymphoma Stem cell mobilization

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days. intervention 2: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.

intervention 1: Granulocyte colony-stimulating factor plus plerixafor intervention 2: Granulocyte colony-stimulating factor plus placebo

32

0

NCT00103610

[ 0 ]

146

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. The purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.

Diabetes Mellitus Obesity

anti-obesity agents diet therapy diet, reducing obesity overweight risk factors weight loss

null

2

arm 1: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. arm 2: Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.

[ 0, 1 ]

3

[ 5, 0, 5 ]

intervention 1: A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat. intervention 2: In addition to the low fat diet, Orlistat is taken 3 times daily. intervention 3: Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

intervention 1: Low carbohydrate ketogenic diet intervention 2: Orlistat intervention 3: Low-fat diet

1

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

0

NCT00108524

[ 4 ]

59

NON_RANDOMIZED

SINGLE_GROUP

null

0NONE

false

0ALL

null

This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Narcolepsy

Narcolepsy Cataplexy

null

0

null

1

[ 0 ]

intervention 1: Xyrem (sodium oxybate) oral solution

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT00132873

[ 4 ]

241

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.

null

Diabetic Neuropathies Neuralgia

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 150-600mg/day, BID intervention 2: Placebo

intervention 1: pregabalin intervention 2: Placebo

10

Sungnam-si | Gyeonggi-do | South Korea | N/A | N/A Suwon | Gyeonggi-do | South Korea | 127.00889 | 37.29111 Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Gwangju | N/A | South Korea | 126.91556 | 35.15472 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

0

NCT00141219

[ 5 ]

194

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.

null

Hypercholesterolemia

Pediatric hypercholesterolemia colesevelam

null

3

arm 1: colesevelam HCl 3.750 g arm 2: Low dose colesevelam 1.875 g arm 3: placebo comparator

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Tablets intervention 2: Matching Tablets

intervention 1: colesevelam HCl intervention 2: placebo

25

0

NCT00145574

[ 5 ]

171

RANDOMIZED

FACTORIAL

1PREVENTION

0NONE

null

0ALL

null

The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.

null

Liver Transplant

Liver transplant, adults, C2 monitoring

null

2

arm 1: Cyclosporine A was given in a twice-daily schedule at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses, as close as possible to 15mg/kg/day. After the first oral administration, the dose of Cyclosporine A was adjusted to bring the sample taken 2 hours after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. C-2h target ranges post-transplantation: 0-3 months: range of 800-1200 ng/ml with midpoint of 1000 ng/ml; 4-6 months: range of 700-900 ng/ml with midpoint of 800 ng/ml; \> 6 months: range of 500-700 ng/ml with midpoint of 600 ng/ml is recommended. During the course of the study, the dose of Cyclosporine A was adjusted as necessary to achieve and maintain the C-2h blood Cyclosporine A (CsA) concentrations within the target ranges. arm 2: Tacrolimus was given on a twice-daily schedule at 12-hour intervals which had to be maintained throughout the study period. Tacrolimus was administered within the first 24 hrs postoperatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the patient can swallow. The initial dosing level was determined by the patient's overall post-operative condition. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the pre-dose blood concentration (C-0h) (trough) tacrolimus concentrations. C-0h target ranges post-transplantation: 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml; \> 6 months: range of 5-10 ng/ml is recommended.

[ 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. intervention 4: Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery intervention 5: Post-operatively prednisone was tapered from an initial dose of 20mg/day to zero at 3 months or continued at 5-10mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.

intervention 1: Cyclosporine A intervention 2: Tacrolimus intervention 3: Basiliximab intervention 4: Methylprednisolone intervention 5: Prednisone

1

Basel | N/A | Switzerland | 7.57327 | 47.55839

0

NCT00149994

[ 3 ]

51

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

true

The purpose of this study is to determine whether a commercially available anti-digoxin antibody, Digibind, can delay delivery in patients with severe pre-eclampsia. If so, this would allow more time for maternally administered steroids to prevent the development of respiratory complications in premature infants.

Preeclampsia (PE) is a serious complication of third trimester pregnancy manifested by high blood pressure, proteinuria, edema, encephalopathy sometimes with seizures, and hepatic failure. There is no known specific treatment, although palliative measures such as antihypertensive drugs, magnesium, steroids and early delivery improve outcomes. Multiple abnormalities have been demonstrated in PE but the relation of these abnormalities to the cause, pathophysiology and treatment is unknown. One of these abnormalities is elevation in the circulating level of a "digoxin-like" factor (EDLF), an unknown substance that cross reacts with digoxin antibodies and inhibits Na,K ATPase. An extensive literature supports the hypothesis that increased levels of EDLF may be a causative factor in the pathogenesis of hypertension. Increased levels of this factor are found both in maternal and fetal blood, both in normal pregnancy, and in pregnancy complicated by PE. Levels of this factor are higher in PE than in normal pregnancy suggesting it might play a role in the pathophysiology of PE. Digibind (Glaxo Smith Kline) is a commercially available FAB fragment, antidigoxin antibody approved for the treatment of digoxin intoxication. In experimental models of hypertension with elevated EDLF levels, Digibind has been shown to lower blood pressure, suggesting that the antibody cross reacts with EDLF. These observations have led to the hypothesis that Digibind might ameliorate some of the manifestations of PE, especially the hypertension. Based on an extensive pre-clinical literature supporting that hypothesis, and encouraging results in 8 cases, a clinical trial is planned to test the effect of Digibind in severe PE. The study is a multi- site, parallel, double blind, placebo controlled, randomized trial. After randomization, 50 patients will be given the usual treatment for severe PE, plus study drug (Digibind or placebo) every six hours, for 48 hours. The study may be terminated during the treatment period for standard indications for early delivery. Data collection will include: delivery latency, maternal blood pressure, antihypertensive use, renal function, hepatic function, CBC and platelet count, and umbilical artery blood flow by color doppler. Standard maternal and fetal monitoring will be followed. Newborn assessment will include: status at birth, APGAR score, NICU length of stay, respirator use and duration, and any medical complications. Adverse events will be recorded.

Pre-eclampsia

Pre-eclampsia Hypertension Endogenous digitalis-like factor Anti-digoxin antibody Digibind

null

2

arm 1: Digibind treatment plus standard of care arm 2: None

[ 1, 2 ]

2

[ 0, 10 ]

intervention 1: intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours. intervention 2: None

intervention 1: Anti-digoxin antibody (FAB fragment) intervention 2: sodium chloride

8

0

NCT00158743

[ 0 ]

64

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.

This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) were included. The included patients were randomized to one out of three possible options: 1. Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up. 2. Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up. 3. No specific treatment (controls), 5 month follow-up.

Headache

Medication-overuse headache preventative medication controls follow-up randomized abrupt withdrawal

null

3

arm 1: Use of preventive drugs from the start without abrupt withdrawal arm 2: Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week arm 3: Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment

[ 1, 5, 5 ]

1

[ 0 ]

intervention 1: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)

intervention 1: Betablockers or other preventive drugs based on primary headache type

1

Trondheim | N/A | Norway | 10.39506 | 63.43049

0

NCT00159588

[ 5 ]

121

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

true

0ALL

false

To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.

null

Attention Deficit Hyperactivity Disorder Reading Disorder

null

4

arm 1: Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks arm 2: Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks arm 3: Normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population. arm 4: The reading disordered control group is comprised of children with reading disorder who receive standard remedial teaching therapy.

[ 0, 0, 4, 4 ]

2

[ 0, 0 ]

intervention 1: Atomoxetine, 1.2 mg/kg/day, by mouth (PO) intervention 2: Placebo, every day (QD), by mouth (PO)

intervention 1: Atomoxetine Hydrochloride intervention 2: placebo

5

Ghent | N/A | Belgium | 3.71667 | 51.05 Almere Stad | N/A | Netherlands | 5.21413 | 52.37025 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Breda | N/A | Netherlands | 4.77596 | 51.58656 Vught | N/A | Netherlands | 5.2875 | 51.65333

0

NCT00191906

[ 5 ]

171

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.

null

Post-Operative Nausea and Vomiting

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 20 micrograms intravenously (iv) 15 min prior to end of surgery intervention 2: 40 micrograms intravenously (iv) 15 min prior to end of surgery

intervention 1: granisetron intervention 2: granisetron

11

0

NCT00231478

[ 3 ]

26

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer

PRIMARY OBJECTIVES: I. Evaluation of the fraction of patients with increased levels of circulating endothelial cells after 3 weeks of treatment with AZD2171. II. Estimation of the objective response rate (ORR = CR + PR) among patients with refractory breast cancer receiving AZD2171. SECONDARY OBJECTIVES: I. Estimation of the response/stable disease rate (RSDR = CR + PR + SD). II. Characterization of the toxicity associated with AZD2171 in this cohort of patients. III. Analyses to correlate serial quantification of circulating endothelial cells and circulating tumor cells with traditional clinical endpoints including RR and TTP. IV. Develop pharmacodynamic measures of AZ2171 activity based on monocyte count and VEGFR-1 phosphorylation within monocytes. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 3 months. PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer

null

1

arm 1: Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

[ 0 ]

2

[ 0, 10 ]

intervention 1: Given orally intervention 2: Correlative studies

intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00244881

[ 5 ]

121

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.

null

Hepatitis C, Chronic

chronic hepatitis C pegylated interferon alfa-2b ribavirin Asia

null

4

arm 1: Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy arm 2: Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy arm 3: Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy arm 4: Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

[ 1, 1, 0, 1 ]

4

[ 2, 0, 2, 0 ]

intervention 1: Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 2: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks intervention 3: Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 4: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks

intervention 1: peginterferon alfa-2b intervention 2: ribavirin intervention 3: peginterferon alfa-2b intervention 4: ribavirin

0

null

0

NCT00255008

[ 4 ]

447

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.

Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. The total study duration will be up to one year. There is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. The primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. The study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by the patient for each migraine headache for which they take almotriptan malate. Migraine pain information and almotriptan malate use will be recorded in the headache diary. An equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. Study medication will be taken for up to one year.

Migraine

Migraine Almotriptan Malate Headache Triptan

null

1

arm 1: Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

[ 0 ]

1

[ 0 ]

intervention 1: Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

intervention 1: Almotriptan Malate

49

0

NCT00257010

[ 4 ]

826

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

null

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

null

Atrophy Vaginal Diseases

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

null

3

arm 1: Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. arm 2: Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. arm 3: Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

[ 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 2: 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 3: 1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 4: Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

intervention 1: Ospemifene 30 mg intervention 2: Ospemifene 60 mg intervention 3: Placebo intervention 4: Nonhormonal vaginal lubricant

0

null

0

NCT00276094

[ 4 ]

494

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.

Study C119 was a multicenter, randomized, double-blind, controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy. Eligible subjects had painful HIV-associated neuropathy resulting from HIV disease and/or antiretroviral drug exposure in both feet, with average numeric pain rating scale (NPRS) scores during screening of 3 to 9 (inclusive). Up to four patches covering an area of up to 1120 square centimeters could be used during a single treatment administration in this study. Subjects were randomly assigned to receive active NGX-4010 patches (8% capsaicin) or low-concentration control patches (0.04% capsaicin) identical in appearance, at doses (patch application duration) of either 30 or 60 minutes, according to a 2:1:2:1 allocation scheme. Subjects could be on stable chronic oral pain medication regimens, but could not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours were recorded daily in the evening, beginning on the day of the Screening Visit (usually on Day -14). Subjects continued to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12. Subjects returned for interim follow-up visits at Weeks 4 and 8 following study treatment.

Pain HIV Infections Peripheral Nervous System Diseases

Analgesics Capsaicin Neuropathic pain Neuropathy Distal sensory polyneuropathy Peripheral neuropathy Dermal assessment Pain measurement

null

4

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

[ 0, 0, 5, 5 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes. intervention 2: Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes. intervention 3: Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes. intervention 4: Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes.

intervention 1: NGX-4010, 8% capsaicin patch intervention 2: 0.04% capsaicin patch intervention 3: NGX-4010, 8% capsaicin patch intervention 4: 0.04% capsaicin patch

0

null

0

NCT00321672

[ 5 ]

219

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).

null

Osteoarthritis

OA Elderly Pain OA of the hips and/or knees

null

2

arm 1: Buprenorphine transdermal 7 day analgesic patch arm 2: codeine paracetamol combination tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: buprenorphine transdermal system 5, 10 and 20 mg intervention 2: combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500

intervention 1: Buprenorphine intervention 2: Codeine paracetamol

1

Cambridge | N/A | United Kingdom | 0.11667 | 52.2

0

NCT00324038

[ 3 ]

34

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.

Recent studies have shown synergy between demethylating agents and histone deacetylase inhibitors. In my laboratory, we have developed in vitro models using HL-60 and MOLT4 leukemic cells to study the effects of the combination of decitabine (a 5-azacytidine analogue) and valproic acid. Valproic acid is an antiepileptic agent with histone deacetylase inhibitory capacity. These results indicate that the addition of valproic acid to decitabine has an additive effect on growth inhibition, induction of apoptosis, induction of p57KIP2 and p21CIP1 expression independent of cell cycle arrest. These results were dependent on the dose and duration of treatment but not on the sequence used. Based on this data, we developed a phase I/II study of the combination of decitabine and valproic acid (2003-0314) in patients with leukemia that has shown that valproic acid can be safely administered up to doses of 50 mg/kg orally for 10 days in combination with decitabine, and that this combination has significant activity in patients with relapsed/refractory AML and MDS. All-trans retinoic acid (ATRA) is a biological agent that has been shown to induce cell differentiation in leukemia cell lines and has significant clinical activity in acute promyelocytic leukemia with minimal toxicity. In vitro, the combination of ATRA with either a hypomethylating agent or a histone deacetylase inhibitor has been shown to restore ATRA sensitivity in resistant cells. More recently, a German group has reported that the combination of valproic acid and ATRA has activity in patients with MDS and an excellent toxicity profile. 5-azacytidine is a nucleoside analogue with hypomethylating activity that has been shown in a randomized study to benefit patients with MDS, including an improvement in quality of life. Based on this data, this agent was recently approved by the FDA for its use in patients with MDS, and has become the first line agent for patients with MDS that required therapy. The objectives of the clinical trial are the following: * To determine the maximal tolerated dose of valproic acid (VPA) in combination with 5-azacytidine (5-aza) and all-trans retinoic acid. * To determine the clinical activity of the combination of 5-azacytidine, valproic acid and all-trans retinoic acid in patients with AML and MDS. * To determine the in vivo molecular and biological effects of this combination. These will include analysis of changes in Deoxyribonucleic acid (DNA) methylation, histone modifications, and gene expression.

Myelodysplastic Syndrome Acute Myelogenous Leukemia

Combination Chemotherapy MDS High-Risk Myelodysplastic Syndrome AML Acute myelogenous leukemia valproic acid VPA Depakene 5-azacytidine 5-aza Azacitidine 5-AZC Vidaza AZA-CR Ladakamycin NSC-102816 All-trans retinoic acid ATRA Tretinoin Vesanoid

null

1

arm 1: Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m\^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m\^2 orally daily (in two divided doses) for 5 days starting on day 3.

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Start at 75 mg/m\^2 subcutaneously daily for 7 days. intervention 2: 50 mg/kg daily by mouth for 7 days, same days as 5-aza. intervention 3: 45 mg/m\^2 orally daily (in two divided doses) for 5 days starting on day 3 of the administration of 5-aza and VPA.

intervention 1: 5-Azacytidine (5-aza) intervention 2: Valproic Acid intervention 3: All-Trans Retinoic Acid (ATRA)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00326170

[ 3, 4 ]

123

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

null

Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.

This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.

Procedural Sedation

Arthroscopy AV Shunt Bunion Dilatation and Curettage Esophagogastroduodenoscopy Hysteroscopy Lithotripsy Rotator Cuff/ Shoulder Transesophageal Echocardiography Ureteroscopy AQUAVAN Sedation

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: AQUAVAN® (fospropofol disodium) Injection

15

0

NCT00327392

[ 4 ]

367

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.

Patients undergoing hip replacement often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503, in an immediate release, (IR) formulation, compared with no drug (placebo) or one dose level of oxycodone (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain from hip replacement surgery. The study will include a blinded 72 hour in-patient phase immediately following hip replacement surgery, during which patients will be treated with either 50-, 75-, or 100-mg CG5503 base IR, a placebo, or 10-mg oxycodone, and pain relief will be periodically assessed. Following this phase, patients wishing to continue treatment with CG5503 IR may enter an outpatient voluntary nonrandomized, open-label extension phase for 9 days during which they will receive 50- or 100-mg CG5503 IR. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR) and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and oxycodone. The null hypothesis for the study is that efficacy results for all CG5503 IR dosage groups are equal to placebo based on the mean sum of pain intensity difference at 48 hours. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours. CG5503 base IR 50, or 75, or 100 mg, or oxycodone 10 mg, or placebo, 1 capsule taken by mouth every 4 to 6 hours during the 72 hour postsurgery phase of the study (one extra dose is allowed, if needed for pain); and CG5503, 50 mg base capsules, 1 to 2 tablets taken by mouth every 4 to 6 hours for up to 9 days during the open label portion of the study. All doses of study treatment will be taken with approximately 120 mL of water with or with food.

Arthroplasty

Arthralgia Pain Pain Assessment Hip Replacement Tapentadol

null

4

arm 1: Placebo Fixed Dose Matching placebo for 3 days arm 2: Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days arm 3: Tapentadol IR (CG5503) Fixed Dose 50, 75, \& 100 mg BID for 3 days arm 4: Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days

[ 2, 1, 0, 5 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Fixed Dose 50, 75, \& 100 mg BID for 3 days intervention 2: Fixed Dose Matching placebo for 3 days intervention 3: Fixed Dose 10 mg BID for 3 days intervention 4: Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days

intervention 1: Tapentadol IR (CG5503) intervention 2: Placebo intervention 3: Oxycodone HCL IR intervention 4: Tapentadol IR (CG5503)

77

0

NCT00364533

[ 4 ]

325

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo. The primary study objective was to compare the efficacy of XP13512 1200 mg taken once daily for 12 weeks versus placebo. The secondary study objectives were to assess the efficacy of XP13512 600 mg taken once daily for the reatment of RLS and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both XP13512 1200 mg and 600 mg.

Restless Legs Syndrome

null

3

arm 1: XP13512 600MG ONCE DAILY arm 2: XP13512 1200MG ONCE DAILY arm 3: PLACEBO ONCE DAILY

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: XP13512 600MG ONCE DAILY intervention 2: XP13512 1200MG ONCE DAILY intervention 3: PLACEBO ONCE DAILY

intervention 1: XP13512 600MG intervention 2: XP13512 1200MG intervention 3: PLACEBO

0

null

0

NCT00365352

[ 5 ]

49

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

1FEMALE

false

This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS) patients.

null

Irritable Colon

mucosal blood flow d-IBS

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: alosetron

1

London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00370032

[ 3 ]

107

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

null

This is a study comparing the activity of lapatinib versus placebo followed by chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced squamous cell carcinoma of head and neck.

null

Squamous Cell Carcinoma of Head and Neck

squamous cell carcinoma of head and neck lapatinib ErbB1/ErbB2 inhibitor apoptosis

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Lapatinib oral tablets intervention 2: Placebo

9

Caen | N/A | France | -0.35912 | 49.18585 Montpellier | N/A | France | 3.87635 | 43.61093 Villejuif | N/A | France | 2.35992 | 48.7939 Athens | N/A | Greece | 23.72784 | 37.98376 Bangalore | N/A | India | 77.59369 | 12.97194 Thiruvananthapuram | N/A | India | 76.94924 | 8.4855 Lima | Lima Province | Peru | -77.02824 | -12.04318 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165

0

NCT00371566

[ 5 ]

9

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Objective: This study is designed to determine whether growth hormone treatment in children 8 to 18 years of age alters function of the lining of the arteries. This may play a role in increasing or decreasing the risk of heart disease. Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be studied before and 3 months after starting growth hormone. Subjects can be on other hormonal replacements but no other medications. Each study will be done in the fasting state. The blood vessel function will be determined by measuring the change in forearm blood flow before and after blocking flow to the arm for 5 minutes. Blood will be drawn after the test to measure glucose, insulin and fats.

The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) is affected by growth hormone treatment in children and adolescents. Poor function by the blood vessels is associated with increased risk of heart disease or stroke. This research is being done because growth hormone treatment has been shown to make the endothelium work better in adults. Growth hormone treatment may have the same or different effects in children because the dose is larger in children. Children between 8 and 18 years who are to be started on growth hormone will be eligible to participate. Blood vessel function will be studied before starting growth hormone and 3 months after. This will be done by measuring blood flow to the arm before and after 5 min of stopping blood flow to the arm. The three months of growth hormone will be given free.

Growth Hormone Deficiency Panhypopituitarism Short Stature

growth hormone endothelial function

null

1

arm 1: Growth hormone treatment 0.3 mg/kg/min

[ 0 ]

1

[ 0 ]

intervention 1: Growth Hormone treatment

intervention 1: growth hormone

1

Columbus | Ohio | United States | -82.99879 | 39.96118

0

NCT00373386

[ 1 ]

11

NA

SINGLE_GROUP

null

1SINGLE

true

0ALL

true

Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: 1. To define the maximum safe dose of a seven day continuous administration of parathyroid hormone \[PTH(1-34)\] in healthy human volunteers. 2. To estimate the effect of a seven day continuous administration of parathyroid Hormone (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and fractional excretion of urine.

This study will expand upon earlier infusions studies that demonstrated: 1) There is a dose-related increase in 1,25 (OH)2 vitamin D in response to PTHrP and PTH over multiple days. 2) There is a markedly attenuated vitamin D response to PTHrP compared to PTH, particularly during the second 24 hours. 3) The increase in 1,25 (OH)2 vitamin D is almost certainly responsible for the greater calcemic effect of PTH compared to PTHrP. 4) PTHrP is obviously a weaker agonist of 1,25 (OH)2 vitamin D but does not result in its suppression as is seen in Humoral Hypercalcemia of Malignancy (HHM). Thus, the suppression of 1,25 (OH)2 vitamin D seen in HHM remained unexplained. In addition to assessing the effects of an infusion of PTHrP and PTH on calcium handling and 1,25(OH)2 vitamin D, we also measured their effects on markers of bone turnover. Given the clinical observations seen in Hyperparathyroidism (HPT) and HHM, we anticipated that PTH would stimulate both bone resorption and formation, while PTHrP would stimulate bone resorption but inhibit formation. However, we observed that infusions of PTHrP and PTH resulted in an equivalent, rapid increase in bone resorption as measured by N-telopeptide (NTx) and C-telopeptide (CTx), as well as a progressive decline in bone formation. There was no difference between PTH and PTHrP. We assumed that formation would ultimately increase with additional time, as seen in HPT, and therefore examined an additional group of subjects infused with PTHrP for 96 hours. However, N-terminal propeptide of type 1 procollagen (P1NP) continued to decline even further as is seen in HHM in contrast to HPT. We have not yet studied longer infusions of PTH. One of the reasons for doing this pilot study is to determine the optimal dosing of PTH over a week period of time. Intravenous PTH has never been infused into human beings for prolonged periods of time. The investigators question whether a prolonged continuous intravenous infusion of PTH will lead to a sustained and progressive suppression of bone formation as occurs in HHM or an increase in bone formation as occurs in HPT. They also want to assess the direct influence of long-term continuous PTH infusions on plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers. We have shown in our previous studies that doses of 8 picomoles (pmol)/kg/hr PTH given over 48 hours result in sustained mild serum hypercalcemia, with serum calcium seeming to plateau in the range of 11 - 11.5 mg/dL after 48 hours. A dose of 8 picomoles (pmol)/kg/hr has also been shown to cause desirable effects on serum 1,25(OH)2 vitamin D and markers of bone turnover, and may therefore be the "ideal" dose. However, we do not know whether serum calcium will plateau after an infusion of 48 hours with escalating doses or whether it will continue to increase over seven days. To determine what will happen with a prolonged infusion, we plan to start with doses lower than 8 picomoles (pmol)/kg/hr, and then gradually increase the dose of PTH in successive groups of subjects. In the event of a significant adverse effect, immediate action will be taken to reverse it. Protocols will be in place to follow in the event of expected adverse events such as hypotension, nausea, and muscle cramping. Severe sudden side effects are not anticipated; however, mild easily reversible side effects are to be expected as an outcome in order to determine the optimal dose of PTH. This study has been approved by the NIH and the Data Safety Monitoring Board (DSMB). Seventy five normal healthy men and women will be screened for an eight day in-patient admission to the General Clinical Research Center (GCRC). Thirty evaluable research participants will receive a seven day infusion of a predetermined dose of PTH. Vitals signs, blood pressure, blood and urine lab results will be monitored frequently as per the study flow sheet. The starting dose of PTH, 2 picomoles (pmol)/kg, will be given to three normal healthy subjects. The dose will be escalated in increments with successive groups of three subjects each, until early adverse effects (mild hypercalcemia, postural hypotension, tachycardia) are seen. This dose will then be used in future studies. The investigators with this study are trying to discover if a prolonged continuous intravenous infusion of PTH will lead to a sustained and progressive suppression of bone formation as occurs in HHM or an increase in bone formation as occurs in HPT. Subject Population will consist of healthy young adults, ages 24-35 years, as in our other safety and physiologic studies. It is anticipated that we will need to screen 75 subjects in order to obtain 30 evaluable subjects.

Osteoporosis Bone Diseases, Endocrine Hyperparathyroidism

Endocrine System Diseases MusculoSkeletal System Disease Hormone Physiologic Properties

null

2

arm 1: Parathyroid Hormone (PTH) (1-34) 2 picomols/kg/hr for one week. arm 2: Parathyroid Hormone (PTH) (1-34)4 picomols/kg/hr for one week.

[ 0, 0 ]

1

[ 0 ]

intervention 1: PTH(1-34) IV given over a one week period

intervention 1: Parathyroid Hormone (1-34)

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00377312

[ 4 ]

338

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

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

null

Major Depressive Disorder

Major Depressive Disorder MDD

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Quetiapine

43

0

NCT00388973

[ 3 ]

22

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.

Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of plerixafor to a granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to apheresis. Participants will undergo mobilization with G-CSF (10 mcg/kg each day) and will receive plerixafor (240 mcg/kg) in the evening prior to apheresis. Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem cells (≥ 5\*10\^6 CD34+ cells/kg for either single or tandem transplant). After apheresis, all participants will be treated with high-dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The increase in CD34+ cells in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and the number of CD34+ cells in the apheresis product will be measured. Success of the transplantation(s) will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMN). A subpopulation will have pharmacokinetic and pharmacodynamic analysis done. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Multiple Myeloma Lymphoma, Non-Hodgkin

Non-Hodgkin's Lymphoma Multiple Myeloma stem cell mobilization AMD3100 autologous transplantation

null

2

arm 1: Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. arm 2: Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

intervention 1: G-CSF Plus Plerixafor

2

0

NCT00396266

[ 4 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

null

This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.

null

Hypertension

hypertension valsartan atenolol hydrochlorothiazide microcirculation arterial compliance pulse wave analysis

null

2

arm 1: After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning. arm 2: After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning.

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 100 mg tablets orally once a day (od) in the morning. intervention 2: 12.5 or 25 mg tablets orally once a day (od) in the morning. intervention 3: 80 mg, 160 mg, or 320 mg tablets orally once a day in the morning

intervention 1: Atenolol intervention 2: Hydrochlorothiazide (HCTZ)) intervention 3: Valsartan

2

Investigative Centers | N/A | Germany | N/A | N/A Basel | N/A | Switzerland | 7.57327 | 47.55839

0

NCT00396656

[ 5 ]

192

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

null

Hypertension

Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Angiotensin Converting Enzyme Inhibitor Hydrochlorothiazide Stage I and II Hypertension Type II Diabetes

null

1

arm 1: Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Olmesartan medoxomil tablets, once daily intervention 2: Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary

intervention 1: olmesartan medoxomil intervention 2: Olmesartan medoxomil plus Hydrochlorothiazide

27

0

NCT00403481

[ 3 ]

42

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

true

The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.

We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation \>90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique: Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Status Asthmaticus

Status asthmaticus Asthma Helium Children

null

2

arm 1: Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. arm 2: Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Subjects will be treated with continuous albuterol nebs with Heliox intervention 2: Subjects will be treated with continuous albuterol nebs in oxygen

intervention 1: Helium-oxygen-driven albuterol nebulizer intervention 2: Oxygen

1

Cincinnati | Ohio | United States | -84.51439 | 39.12711

0

NCT00410150

[ 4 ]

1,670

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

null

Acne Vulgaris

Acne vulgaris Adapalene Benzoyl Peroxide

null

4

arm 1: Adapalene/Benzoyl Peroxide Topical Gel arm 2: Adapalene Topical Gel arm 3: Benzoyl Peroxide Topical Gel arm 4: Topical Gel Vehicle

[ 0, 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Topical Gel, One application daily in the evening for 12 weeks intervention 2: Topical Gel,One application daily in the evening for 12 weeks intervention 3: Topical Gel, one application daily in the evening for 12 weeks intervention 4: Topical Gel Vehicle,one application daily in the evening for 12 weeks

intervention 1: Adapalene/Benzoyl Peroxide intervention 2: Adapalene intervention 3: Benzoyl Peroxide intervention 4: Topical Gel Vehicle

62

0

NCT00421993

[ 4 ]

429

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to standard treatment before primary PCI of STEMI patients with respect to effect on sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial reperfusion

null

Infarction, Myocardial

Eptifibatide ST-elevation Myocardial Infarction STEMI Abciximab

null

2

arm 1: Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI. arm 2: Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mcg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI. intervention 2: Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mdg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.

intervention 1: Abciximab intervention 2: Eptifibatide

24

Alençon | N/A | France | 0.09311 | 48.43476 Bordeaux | N/A | France | -0.5805 | 44.84044 Caen | N/A | France | -0.35912 | 49.18585 Créteil | N/A | France | 2.46569 | 48.79266 Lille | N/A | France | 3.05858 | 50.63297 Melun | N/A | France | 2.65356 | 48.5457 Melun | N/A | France | 2.65356 | 48.5457 Nancy | N/A | France | 6.18496 | 48.68439 Ollioules | N/A | France | 5.84766 | 43.1399 Pau | N/A | France | -0.35583 | 43.31117 Perpignan | N/A | France | 2.89541 | 42.69764 Pessac | N/A | France | -0.6324 | 44.80565 Toulon | N/A | France | 5.92836 | 43.12442 Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115 Freiburg im Breisgau | Baden-Wurttemberg | Germany | 7.85222 | 47.9959 Heidelberg | Baden-Wurttemberg | Germany | 8.69079 | 49.40768 Würzburg | Bavaria | Germany | 9.95121 | 49.79391 Offenbach | Hesse | Germany | 8.76647 | 50.10061 Aachen | North Rhine-Westphalia | Germany | 6.08342 | 50.77664 Dortmund | North Rhine-Westphalia | Germany | 7.466 | 51.51494 Mönchengladbach | North Rhine-Westphalia | Germany | 6.44172 | 51.18539 Neuss | North Rhine-Westphalia | Germany | 6.68504 | 51.19807 Ludwigshafen am Rhein | Rhineland-Palatinate | Germany | 8.44641 | 49.48121 Homburg | Saarland | Germany | 7.33867 | 49.32637

0

NCT00426751

[ 4 ]

150

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

null

This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity Disorder (ADHD).

null

Attention Deficit Hyperactivity Disorder

ADHD methylphenidate children food effect Attention-Deficit Hyperactivity Disorder (ADHD) in children

null

2

arm 1: Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. arm 2: Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.

[ 0, 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Methylphenidate 20 mg long-acting capsules

1

Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959

0

NCT00428792

[ 4 ]

1,703

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.

null

Migraine

null

4

arm 1: MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack arm 2: MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack arm 3: MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack arm 4: Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

intervention 1: MK0974 50 mg intervention 2: MK0974 150 mg intervention 3: MK0974 300 mg intervention 4: Comparator: Placebo

0

null

0

NCT00432237

[ 3 ]

85

RANDOMIZED

PARALLEL

1PREVENTION

1SINGLE

true

1FEMALE

false

The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.

For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase. After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.

Infertility, Female

Assisted Reproductive Technology (ART) oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies

null

2

arm 1: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. arm 2: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. intervention 2: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.

intervention 1: Degarelix mid-luteal, 2.5 mg intervention 2: Placebo

4

Brussels | N/A | Belgium | 4.34878 | 50.85045 Prague | N/A | Czechia | 14.42076 | 50.08804 Madrid | N/A | Spain | -3.70256 | 40.4165 Valencia | N/A | Spain | -0.37966 | 39.47391

0

NCT00434122

[ 2 ]

27

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study. Trial finished and no further data will be collected.

Metastatic Pancreatic Cancer

Pancreatic Cancer

null

4

arm 1: Weekly gem + GW572016, 1000mg/day (combination) arm 2: Weekly gem + GW572016, 1500 mg/day (combination) arm 3: GEMOX + GW572016 1000 mg/day (combination) arm 4: GEMOX + GW572016 1500 mg/day (combination)

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Weekly gem + GW572016, 1000mg/day (combination) intervention 2: Weekly gem + GW572016, 1500 mg/day (combination) intervention 3: GEMOX + GW572016 1000 mg/day (combination) intervention 4: GEMOX + GW572016 1500 mg/day (combination)

intervention 1: cohort 1 intervention 2: cohort 2 intervention 3: cohort 3 intervention 4: cohort 4

1

Providence | Rhode Island | United States | -71.41283 | 41.82399

0

NCT00439179

[ 3 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia

null

Schizophrenia

null

4

arm 1: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 50 mg/day armodafinil treatment arm for the double-blind treatment period of the study took one 50 mg armodafinil tablet plus three placebo tablets each morning. arm 2: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 100 mg/day armodafinil treatment arm for the double-blind treatment period of the study took two 50 mg armodafinil tablets plus two placebo tablets each morning. Subjects began taking 50 mg/day and then titrated to 100 mg/day on Day 2 of the first week of the double-blind treatment period. arm 3: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 200 mg/day armodafinil treatment arm for the double-blind treatment period of the study took four 50 mg armodafinil tablet and no placebo tablets each morning. Subjects were titrated to this dose by starting treatment at 50 mg/day (1 tablet) and increasing by 50 mg increments on days 2, 4, and 6 until they were taking 200 mg/day. arm 4: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the placebo treatment arm for the double-blind treatment period of the study took four placebo tablets and no armodafinil tablets each morning.

[ 1, 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 50 mg/day armodafinil intervention 2: 100 mg/day armodafinil intervention 3: 200 mg/day armodafinil intervention 4: placebo

intervention 1: armodafinil intervention 2: armodafinil intervention 3: armodafinil intervention 4: placebo

12

0

NCT00487942

[ 5 ]

793

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

null

This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.

null

Osteoporosis

zoledronic acid post dose symptoms transient acetaminophen fluvastatin

null

3

arm 1: 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). arm 2: 2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). arm 3: 2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

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

intervention 1: Placebo intervention 2: Acetaminophen intervention 3: Fluvastatin

1

Http://www.osteoporosisclinicalresearch.com | New Jersey | United States | N/A | N/A

0

NCT00489424

[ 3 ]

168

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.

This study will enroll male and female patients with migraine headache with or without aura. The study will randomize \~160 patients, 1:1:1:1 to receive one of the following treatments: 1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato Placebo.

Migraine

Staccato® Loxapine, Migraine

null

4

arm 1: 1.25 mg ADASUVE, single dose arm 2: 2.5 mg ADASUVE, single dose arm 3: 5 mg ADASUVE, single dose arm 4: Staccato Placebo, 0 mg

[ 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: Placebo aerosol inhalation (0mg)

intervention 1: Staccato Loxapine intervention 2: Staccato Placebo

1

Wellesley Hills | Massachusetts | United States | -71.27867 | 42.30843

0

NCT00489476

[ 2 ]

12

RANDOMIZED

PARALLEL

null

4QUADRUPLE

true

0ALL

null

This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.

null

Marijuana Dependence

Marijuana dependence

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Placebo intervention 2: Dronabinol

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00490269

[ 3 ]

83

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.

null

Chronic Obstructive Pulmonary Disease

COPD, Age≥40 yrs, Glycopyrronium Bromide

null

6

arm 1: 12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 2: 25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 3: 50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 4: 100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 5: Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 6: 18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

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

3

[ 0, 0, 0 ]

intervention 1: single-dose dry-powder inhaler (SDDPI) intervention 2: single-dose dry-powder inhaler (SDDPI) intervention 3: Handihaler inhaler

intervention 1: NVA237 intervention 2: Placebo intervention 3: Tiotropium

3

Vilvoorde | N/A | Belgium | 4.42938 | 50.92814 Rueil-Malmaison | N/A | France | 2.18967 | 48.8765 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00501852

[ 3 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary aim of the study is to demonstrate a reduction in circulating interleukin 6 levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when patients are given either ketamine or placebo (0.9% saline in equivalent volume). The alternative (two tailed) hypothesis (HA) if the null is disproved is that ketamine leads to significantly different levels of interleukin 6 at 4 and 24 hours after completion of surgery. We plan to randomize 40 patients to receive either ketamine or placebo, in a block of 4 randomization design stratified by whether surgery is performed by VATS or open lobectomy.

This study is designed to be a phase 2 (efficacy) randomized controlled clinical trial of ketamine versus placebo in 40 patients undergoing lobectomy by VATS or open approach, at Duke University. We selected a single dose regimen of 0.5mg/kg IV ketamine given at induction of anesthesia, as this is the dose that previously has been shown to induce maximal suppression of the IL-6 response in cardiac surgery. We plan to randomize 40 patients to receive either ketamine or placebo, in a block of 4 randomization design stratified by whether surgery is performed by VATS or open lobectomy. 40 patients (n=20 per group) will provide 90% power to detect a change in IL 6 of 20 pg/ml from a mean of 100 pg/ml at 4 hours, with two tailed alpha = 0.05. Allowing for 10-20% attrition we will enroll 50 patients to achieve this sample size. All patients presenting for lobectomy either VATS or open will be included. Patients will be screened by review of the preoperative surgical schedule posted each day and approached for consent to participate if they do not have any exclusion criteria. Patients who are randomized but do not undergo lobectomy for any reason will not be included in the analysis of the primary endpoint. Patients who are listed for VATS resection but convert to open will be included in the analysis on a per protocol basis. The randomization is stratified according to planned approach (VATS vs open), however we expect the majority of these cases to be VATS lobectomies. Treatment will be by intravenous administration of a single dose of study drug over 5 minutes immediately after induction of anesthesia and before surgical incision. Patients will be randomized (by sealed envelope) in blocks of 4 to receive ketamine or placebo. The randomization will be stratified according to whether the planned surgery is via VATS or open (thoracotomy) approach. The study drug will be prepared by the investigational pharmacy and provided to the attending anesthesiologist of record for the case. It will contain 0.5 mg/kg ketamine for injection by IV bolus over 5 minutes, or as an equivalent volume of 0.9% saline. It will be the responsibility of the principal investigator to ensure that study drug is administered in a timely fashion, usually by delegation to the attending anesthesiologist of record for the case. The anesthetic procedure will be standardized in that each patient will receive a total intravenous anesthetic using propofol and an intravenous opioid infusion. This anesthetic will be supplemented by an epidural and intravenous opioid boluses as needed to control pain. Visits by the research team will be performed as follows: 1. Visit 1 will occur at enrollment, when baseline information (see CRF visit 1) will be collected and study consent forms signed. 2. Visit 2 will occur at induction of anesthesia when study drug will be administered and a baseline blood sample of 10ml collected from the patient's arterial line. The blood sample will be immediately centrifuged and the serum frozen and stored for subsequent analysis. 3. Visit 3 will occur at 4 hours after completion of surgery when 10 ml blood will be collected and CRF visit 3 form will be completed (VAS score and emergence delirium). 4. Visit 4 will occur at 24 hours after completion of surgery when 10 ml blood will be collected and CRF visit 4 form will be completed (VAS score). 5. The final visit will occur just prior to hospital discharge when CRF visit 5 form will be completed (secondary endpoints). Additionally, if the principal investigator is informed by either study staff or the clinical team of an adverse event or other complication, then the patient will be visited within 24 hours for confirmation of the event and ascertainment of whether the event is related to study drug or not. An SAE form will be completed and sent to the IRB in line with institutional policy.

Lung Cancer

Lobectomy VATS

null

2

arm 1: Single bolus 0.5mg/kg ketamine IV after induction of anesthesia arm 2: 0.9 % saline bolus of equivalent volume

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Interventional intervention 2: placebo

intervention 1: Ketamine intervention 2: 0.9% saline

1

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

0

NCT00504725

[ 4 ]

257

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Hypertension

hypertension, valsartan, amlodipine

null

1

arm 1: During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.

[ 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only. intervention 2: Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only. intervention 3: Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase. intervention 4: Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

intervention 1: Amlodipine intervention 2: Olmesartan medoxomil intervention 3: Amlodipine+valsartan intervention 4: Hydrochlorothiazide

2

Schwerin | N/A | Germany | 11.41316 | 53.62937 N/A | N/A | N/A | N/A | N/A

0

NCT00523744

[ 2 ]

48

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

true

0ALL

false

To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.

The planned study is a single dose, double-blind, double-dummy, active and placebo controlled, randomized, 4-period cross-over study investigating investigating 2 doses levels of Staccato Prochlorperazine, a positive control with known QT/QTc prolongation (oral moxifloxacin), and placebo.

Cardiotoxicity

Inhaled prochlorperazine, Thorough Qt/QTc,

null

4

arm 1: Treatment Sequence ABCD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg arm 2: Treatment Sequence BDAC where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg arm 3: Treatment Sequence CABD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg arm 4: Treatment Sequence DCBA where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg

[ 5, 5, 5, 5 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Inhaled Staccato placebo (0 mg) intervention 2: Oral placebo (identical to 400 mg moxifloxacin) intervention 3: Staccato prochlorperazine 5 mg, single dose intervention 4: Inhaled prochlorperazine 10 mg, single dose intervention 5: Oral moxifloxacin 400 mg, si/ngle dose

intervention 1: Inhaled placebo intervention 2: Oral placebo intervention 3: Inhaled prochlorperazine 5 mg intervention 4: Inhaled prochlorperazine 10 mg intervention 5: Oral moxifloxacin

1

Evansville | Indiana | United States | -87.55585 | 37.97476

0

NCT00543062

[ 5 ]

48

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

0NONE

true

0ALL

null

The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers

null

Bacterial Infections Eye Infections

null

8

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

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

2

[ 0, 0 ]

intervention 1: azithromycin topical solution 1% given as a single drop in a single eye intervention 2: Moxifloxacin topical solution given as a single drop in a single eye

intervention 1: Azithromycin intervention 2: Moxifloxacin

0

null

0

NCT00564447

[ 2 ]

33

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.

null

Osteoarthritis, Knee

null

3

arm 1: Ibuprofen arm 2: Placebo 1 arm 3: Placebo 2

[ 1, 2, 2 ]

2

[ 0, 0 ]

intervention 1: Patients will receive 800 mg ibuprofen in one of the three treatment periods. intervention 2: Patients will receive placebo to ibuprofen in two of the three treatment periods.

intervention 1: ibuprofen intervention 2: Placebo

0

null

0

NCT00565084

[ 3 ]

69

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.

null

Pulmonary Tuberculosis

Early Bactericidal Activity EBA pulmonary tuberculosis PA-824 Pretomanid CL-007

null

5

arm 1: PA-824 200 mg/qd arm 2: PA-824 600 mg/qd arm 3: PA-824 1000 mg/qd arm 4: PA-824 1200 mg/qd arm 5: Rifafour e-275 mg

[ 0, 0, 0, 0, 1 ]

1

[ 0 ]

intervention 1: 200 mg, 600 mg, 100 mg, 1200 mg qd

intervention 1: PA-824

2

0

NCT00567840

[ 4 ]

124

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease

null

Parkinson's Disease

Rotigotine NEUPRO Switching trial from ropinirole to rotigotine, safety and tolerability Parkinson disease

null

1

arm 1: Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.

[ 0 ]

1

[ 0 ]

intervention 1: Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application

intervention 1: Rotigotine

0

null

0

NCT00593606

[ 2 ]

26

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

null

The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a specific metabolite (which is a marker of in vivo platelet reactivity).

Subjects will receive 1 of 4 treatments per period and will eventually receive all 4 treatments: Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7 days Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing on Day 7 of a period and dosing on Day 1 of the subsequent period

Type 2 Diabetes Mellitus

null

4

arm 1: Arm A: ER niacin/laropiprant + Placebo to laropiprant arm 2: Arm B: ER niacin + Placebo to laropiprant arm 3: Arm C: laropiprant + Placebo to ER Niacin/laropiprant arm 4: Arm D: Placebo

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: ER niacin 2 g/ laropiprant 40 mg daily for 7 days. intervention 2: ER niacin 2 g daily for 7 days. intervention 3: laropiprant 40 mg daily for 7 days. intervention 4: matching placebo tablets for each of the interventions once daily for 7 days

intervention 1: Comparator: ER niacin (+) laropiprant intervention 2: Comparator: ER niacin intervention 3: Comparator: laropiprant intervention 4: Comparator: placebo

0

null

0

NCT00618995

[ 2 ]

18

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

true

Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.

This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.

Healthy

sumatriptan Intraject Local Site Reactions

null

0

null

1

[ 0 ]

intervention 1: injection

intervention 1: Sumatriptan

0

null

0

NCT00620425

[ 3 ]

414

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and viseral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The objective of this protocol is to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal leishmaniasis (pentavalent antimonials curently considered the drug of choice for these infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is FDA approved for vusceral leishmaniasis).

Leishmaniasis is a protozoal disease transmitted by sandflies and is endemic in many parts of the world including Central and South America, Europe, Southwest Asia, Africa, and the Middle East. Infected humans may develop cutaneous (Old or New World), mucocutaneous (New World), or visceral leishmaniasis. The disease is a medical threat for military soldiers assigned in endemic areas and currently a major cause of morbidity in soldiers deployed to the Middle East and a complication of military exercises in Panama, Honduras, and South America. Pentavalent antimonials (Pentostam, GSK, UK, and Glucantime, Rhone-Poulenc, France) have been used to treat leishmaniasis for more that 50 years. Neither of these drugs are licensed for commercial use in the United States, likely because of limited use. Worldwide, there is a great deal of experience and use of these products. Pentostam or sodium stibogluconate is a pentavalent antimony drug complexed to carbohydrate the exact structure and mechanism of action of which are not known. It is provided as a 100 mg antimony/ml solution that contains a preservative, m-chlorocresol. Most of the dose is excreted by the kidneys within 24 hours. Pentostam is presently an investigational new drug (IND) product that has been in use by the Department of Defense (DoD) for over 20 years for the treatment of cutaneous, mucosal and visceral leishmaniasis. In August, 1997, the FDA approved Ambisome (liposomal amphotericin) for the treatment of visceral leishmaniasis. As a result, in the treatment of visceral and viscerotropic leishmaniasis, the use of antimonials will now be considered a second-line therapy In 1984, the World Health Organization recommended that the daily dose of antimony in the treatment of visceral leishmaniasis be increased to 20 mg/kg/day. A randomized controlled trial of 40 subjects with American, New World, cutaneous leishmaniasis (ACL) found 100% cure rates with 20 mg/kg/day Sb for 20 days but only a 76% cure if 10 mg/kg/day for 10 days was used. A comparison of three treatment schedules in 36 subjects with CL (single rapid infusion, continuous 24 hour infusion, or every eight hour doses) found no advantage over using once daily dosing. A review of the controlled trials of SSG concludes that a recommended course of therapy is 20 mg/kg/day with no upper limit to dose for 20 days for CL and 20 mg/kg/day for 28 days for visceral or mucocutaneous leishmaniasis. The Pentostam® package insert suggests that 10-20 mg/kg/day with a maximum dose of 850 mg for a minimum of 20 days be used; however, based on the Centers for Disease Control and Prevention (CDC) and Walter Reed Army Medical Center (WRAMC) experience and their practice guidelines, 20 mg/kg/day with no upper limit to dosage is used. WRAMC recently published their CL treatment experience primarily in New World leishmaniasis comparing SSG 20 mg/kg for 10 or 20 days and found 100% of volunteers in the 10-day group were cured. In this study 15% were Leishmania major infections. Comparable results are expected for Old World leishmaniasis based on clinical experience and current literature. Detailed toxicity data for the 20 mg/kg/day dose are provided by several studies. Percentages from the WRAMC experience are included here. Subjective musculoskeletal complaints are common (58%), as well as elevated hepatocellular (67%) and pancreatic enzyme levels (97%) and nonspecific electrocardiogram (EKG) changes (T wave changes). These side effects are usually reversible, and no deaths have been associated with SSG at WRAMC. Other SSG toxic effects include headache (22%), rash (9%), thrombocytopenia, depression of various hematologic cell lines (44%), phlebitis, anaphylaxis, inflammation around lesions, and transient coughing after infusion. Other associated symptoms include anorexia, malaise, myalgia, abdominal pain, headache, lethargy, sweating, vertigo, facial flushing, initial worsening of skin lesions, epistaxis, jaundice and peripheral neuropathy. In our above-mentioned 10 versus 20 days study, the adverse events (AE) were significantly decreased in the cohort receiving the 10 days versus 20 with myalgias in 42% (versus 68%), with less chemical pancreatitis and fewer hematologic parameter disorders. Angioedema during SSG infusion has recently been described in two subjects at WRAMC. Both subjects responded quickly to benadryl treatment without complications. Both subjects were subsequently skin tested with SSG intradermally for hypersensitivity and one reacted. Alternative heat therapies have been used to successfully treat CL. Laboratory investigation showed that Leishmania infection is sensitive to heat. Various forms of heat application in human CL has shown variable efficacy. The TTI Thermomed™ device has been cleared as a 510-k device by the U.S. Food and Drug Administration (FDA) for use in the treatment of CL. This device uses localized current field radio frequency. Other therapies that may be effective for treating CL include topical paromomycin and oral fluconazole.

Leishmaniasis

Leishmaniasis Sodium stibogluconate Pentostam sand fly

null

1

arm 1: All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.

[ 0 ]

1

[ 0 ]

intervention 1: 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

intervention 1: Sodium Stibogluconate (SSG)

1

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

0

NCT00662012

[ 5 ]

60

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

null

Opiate-related Disorders Opiate Dependence Drug Abuse

Suboxone Subutex Buprenorphine Naloxone

null

1

arm 1: Subutex® for first two days of study followed by Suboxone® for last 3 days of study

[ 0 ]

2

[ 0, 0 ]

intervention 1: 2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study intervention 2: 2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study

intervention 1: buprenorphine intervention 2: buprenorphine/naloxone

0

null

0

NCT00684073

[ 5 ]

21

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

2DOUBLE

false

1FEMALE

true

This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.

null

Neuropathic Pain Postmastectomy Pain

breast cancer neuropathic pain topical lidocaine postmastectomy pain breast symptoms breast pain

null

2

arm 1: Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day. arm 2: Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 1 patch was applied topically to the affected site(s) for 12 hours each day. intervention 2: 1 patch was applied topically to the affected site(s) for 12 hours each day.

intervention 1: Lidoderm patch intervention 2: Placebo patch

1

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

0

NCT00686127

[ 4 ]

43

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

1FEMALE

false

A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to: 1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood)

Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern. Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.

Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Overweight Adolescent Girls Irregular Menstrual Cycles

null

4

arm 1: Metformin arm 2: Oral Contraceptive Pills arm 3: lifestyle modification program arm 4: placebo to active metformin arm

[ 0, 0, 1, 2 ]

4

[ 0, 0, 5, 0 ]

intervention 1: Metformin 425mg. capsules, 2 capsules BID x 24 weeks intervention 2: Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks intervention 3: weekly classes x 24 weeks for training in diet, exercise and behavior modification skills intervention 4: placebo to the active metformin arm. 2 capsules BID x 24 weeks.

intervention 1: Metformin intervention 2: Oral Contraceptive Pills (Yasmin) intervention 3: Lifestyle Modification intervention 4: placebo

0

null

0

NCT00714233

[ 4 ]

120

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

null

Gingivitis

Gingivitis and Plaque

null

2

arm 1: triclosan/copolymer/fluoride toothpaste arm 2: sodium fluoride only toothpaste (placebo)

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Six Month study, brush twice daily intervention 2: twice daily usage

intervention 1: Triclosan, fluoride intervention 2: Fluoride

1

Barcelona | N/A | Spain | 2.15899 | 41.38879

0

NCT00926328

[ 5 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

1FEMALE

false

The objective of this study is to compare the action halos of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.

This was a monocentric, prospective, randomized and double-blind study. Fifty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. There were two randomizations, one related to the dose-equivalence (2:1U and 2.5:1U), both reconstituted in the same volume of 0.02 mL per point and another related to the forehead side (left or right) for application of the tested drugs. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

Wrinkles in Frontal Area

Muscular activity wrinkles in frontal area action halos

null

2

arm 1: BoNT A1 (4U): Botulinum toxin A (Dysport®)4 units arm 2: BoNT-A2(2U): Botulinum toxin A (Botox®) 2 units

[ 1, 1 ]

1

[ 0 ]

intervention 1: On Visit 1 (Day 0): Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site. * Dysport®: 4 units will be injected in the left or right forehead side. * Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)

intervention 1: BOTULINUM TOXIN TYPE-A

1

Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283

0

NCT00959907

[ 4 ]

22

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

true

0ALL

false

Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing

null

Salivary Bacteria Levels

null

2

arm 1: fluoride toothpaste control arm 2: triclosan/fluoride toothpaste

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Whole mouth brushing for 7 days intervention 2: Brush whole mouth twice daily for 7 days

intervention 1: Fluoride intervention 2: Triclosan/Fluoride

1

Mumbai | N/A | India | 72.88261 | 19.07283

0

NCT00981825

[ 5 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

1FEMALE

false

The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.

This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

Wrinkles in Frontal Area

Botulinum toxin type A field effects dose-equivalence anhydrotic action halos

null

1

arm 1: Dysport® compared to Botox®

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 5 units will be injected in the left or right forehead side. intervention 2: 2 units will be injected in the left or right forehead side.(opposite side of dysport injection) intervention 3: Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox.

intervention 1: Botulinum Toxin Type A (Dysport®) intervention 2: Botulinum Toxin Type A/Botox® intervention 3: Botulinum Toxin Type A/Dysport®

1

Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283

0

NCT00989768

[ 2 ]

28

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also determine the bioavailability following a standard high-fat meal and evaluate the safety and tolerability of the test product.

This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5mg with probenecid 500mg), administered under fasting conditions. It will also determine the bioavailability of the test product following a standard high-fat meal and evaluate the safety and tolerability of the test product. Twenty-eight healthy, non-smoking, non-obese (BMI 81-30 kg/m2 and BW ≥110 lbs), 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive one of three dosing regimens in sequence with washout periods of at least 14 days between dosing periods. After a fast of at least 10 hours, subjects will receive either, one tablet of colchicine 0.6 mg, one tablet of colchicine 0.6 mg after a standardized high-fat,high-calorie breakfast or 0.5mg/500mg colchicine/probenecid. All doses will be given with 240mL of room temperature water. Patients will be confined for at least 15 hours before and 24 hours after each dose with daily outpatient visits over the following 3 days. Blood will be drawn at times sufficient to adequately define the concentration time curves for each dosing regimen, which will be compared to assess the bioequivalence of the reference and test products and the effect of food on the test product. Subjects will also be monitored for adverse events throughout this same period.

Healthy

bioequivalence fasting fed healthy

null

3

arm 1: Colchicine (fasted) arm 2: Colchicine (fed) arm 3: Colchicine/Probenecid (fasted)

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 0.6mg tablet administered after a fast of at least 10 hours intervention 2: 0.6mg tablet administered after a standardized high-fat, high-calorie breakfast intervention 3: 0.5mg/500mg tablet administered after a fast of at least 10 hours

intervention 1: Colchicine intervention 2: Colchicine intervention 3: Colchicine/Probenecid

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01021020

[ 4 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

true

0ALL

false

Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.

null

Mucositis

null

2

arm 1: Triclosan/copolymer/fluoride toothpaste arm 2: Fluoride Toothpaste

[ 0, 2 ]

2

[ 0, 0 ]

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

intervention 1: Triclosan and Fluoride intervention 2: Fluoride

1

Rimini | N/A | Italy | 12.56528 | 44.05755

0

NCT01072201

[ 0 ]

42

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the leading infectious cause of blindness in the world.Treatment of C. trachomatis eye infection has involved for a long time. The efficacy of single dose azithromycin has already been demonstrated as effective in the treatment of both trachoma and adult inclusion conjunctivitis.However, in our clinical experience, some patients of chlamydial conjunctivitis may require augmented single dose azithromycin treatments before C. trachomatis is eradicated. In this way, we would like to known the efficacy of single dose and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.

Medical records of patients with clinically suspected chlamydial conjunctivitis between January 1, 2006 and December 31, 2006 at one cornea specialist's (Y.C.H) out-patient clinic were retrospectively reviewed. At this clinic, patients of both sexes with acute, chronic or recurrent follicular conjunctivitis with the symptoms and signs of chlamydial conjunctivitis suspected were tested for Chlamydia direct fluorescent antibody (DFA) tests and arranged for next time out-patient clinic follow up 1-2 weeks later. The patients who attended the follow up visit with positive DFA results were treated with oral azithromycin. These patients received a single dose oral azithromycin (400mg\~1000mg, according to their age and body weight) once a week for consecutive two weeks. Repeated DFA examinations were performed 4 to 6 weeks later. If the DFA examinations still showed positive results, augmented single dose oral azithromycin once a week for one week was given again till the DFA showed negative results. The occurrence and frequency of adverse events recorded in the medical charts were reviewed as well.

Chlamydial Conjunctivitis

Oral Azithromycin Chlamydial Conjunctivitis

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

intervention 1: Azithromycin

1

Taipei | N/A | Taiwan | 121.52639 | 25.05306

0

NCT01178762

[ 4 ]

300

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

1FEMALE

true

Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.

Follicle stimulating hormone (FSH) is a heterodimeric glycoprotein wherein an alfa subunit and a beta subunit are noncovalently bonded. Follicle stimulating hormone is one of the key hormones regulating reproductive functions in both female and male mammals, including humans. In females, it stimulates the development of ovarian follicles, which carry oocytes, while in males it promotes spermatogenesis. Synthesis and secretion of FSH are stimulated by gonadotropin releasing hormone (GnRH), a hypothalamic peptide. Complete or partial deficiencies in FSH secretion are common causes of infertility in men and women. In women, this state is characterized by absence of ovulation or abnormal ovulation. In men, it leads to absence of or abnormally low production of spermatozoa. Administration of FSH, either alone or in combination with luteinizing hormone (LH), has been used successfully to treat these infertility problems. Until recently, only human menopausal gonadotropin (hMG), a mixture of human LH and FSH extracted from the urine of post-menopausal women, and purified FSH (u-hFSH), which could be used to reduce the LH content, had been available for treatment of infertility. In Japan, hMG and u-hFSH are still used to induce ovulation. Purified pituitary gonadotropin, which was used as the comparator drug in this clinical trial, is a urinary gonadotropin preparation. However, it is not classified as hMG, but rather as a purified pituitary gonadotropin (u-hFSH), and is the preparation most commonly used in Japan. Since the LH content of u-hFSH is very low, it can be administered relatively safely, if adequate care is taken, to patients with polycystic ovary syndrome (PCOS). SJ-0021 is a recombinant human FSH (r-hFSH) that is produced using Chinese hamster ovary (CHO) cells as the host cells. The generic name for SJ-0021 is follitropin alfa for injection, and it is marketed overseas as GONAL-f®. It was approved in Japan in January 2006 as being effective in inducing spermatogenesis in cases of male hypogonadotropic hypogonadism (MHH). OBJECTIVES * To examine the efficacy of SJ-0021 versus purified pituitary gonadotropin for ovulation induction and follicle development in subjects with amenorrhea I or anovulatory cycles, and to verify the non-inferiority of SJ-0021 versus the comparator drug * To assess the safety of SJ-0021 This clinical trial comprised of a pretrial observation period, a treatment period \[IMP administration period\], and a post-treatment assessment period. The clinical trial was scheduled in such a way that spontaneous menstruation or withdrawal bleeding induced by progesterone administration occurred within 28 days after the completion of baseline tests conducted during the pretrial observation period. A visit to the trial site was then scheduled for any day between Day 2-5 of the spontaneous menstruation or withdrawal bleeding, during which actual registration of the subject for randomization and pre-administration tests were performed. After completion of pre-administration tests, 75 IU of either SJ-0021 or purified pituitary gonadotropin that was allocated to the subject was subcutaneously administered on the same day (dosing Day 1 of treatment period), and the same daily dose was maintained for the first 7 days of the treatment period. On dosing Day 8, the mean diameter of the dominant follicle was measured; if it was \< 11 mm, the daily IMP dose was increased by 37.5 IU and this new daily dose was administered for the next 7 days. If the mean diameter of the dominant follicle was ≥ 11 mm but \< 18 mm, the same (previous) IMP dose was administered for the next 7 days. If the mean diameter of the dominant follicle had already reached 18 mm or above, administration of the IMP was terminated, and the subject moved on to the post treatment assessment period. Similarly, if the mean diameter of the dominant follicle was \< 11 mm on dosing Day 15 or Day 22, the dose was increased; if it was ≥ 11 mm but \< 18 mm, administration was continued at the same previous dose, and if it was ≥ 18 mm IMP administration was terminated. The maximum dose of IMP that can be administered was 187.5 IU/day and the maximum dosing period for the IMP was 28 days. In addition to Day 8, Day 15 and Day 22, ultrasound examination can be conducted once or twice a week during the treatment period, based on the status of growth of the dominant follicle (and on every visit once the dominant follicle has achieved a maximum diameter of 16 mm). Examinations for the first day of the post-treatment assessment period were conducted, as appropriate, on the day when the mean diameter of the dominant follicle reached ≥ 18 mm or on the day after dosing Day 28 of the IMP. The hCG cancellation criterion (i.e. four or more ovarian follicles with a mean diameter ≥ 16 mm) was also verified at the same time. If the hCG cancellation criterion was not met, a single dose of 5000 IU of hCG was administered intramuscularly, within 24 hours of the last ultrasound examination. Mid-luteal phase tests were conducted on Day 6 ± 1 and Day 9 ± 1 of the post-treatment assessment period, and a final examination was performed on Day 28-31 of the post-treatment assessment period. If the pregnancy test (urine) conducted at this final examination was positive, a further pregnancy test (ultrasound examination) was performed on Day 35-42 of the post-treatment assessment period. On the other hand, if the mean diameter of the dominant follicle remained \< 16 mm on the day after dosing Day 28 of the IMP, or the hCG cancellation criterion was met, hCG administration was withheld, and the examinations for the first day of the post-treatment assessment period as well as the final examination on Day 28-31 of the post-treatment assessment period were performed accordingly.

Infertility Ovulation Induction

Infertility Ovulation induction Gonalef® (Follitropin alfa) Purified pituitary gonadotropin (Fertinorm-P®) gonadotropin Reproductive technologies, assisted Polycystic ovary syndrome

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Subcutaneous administration of follitropin alfa at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met. intervention 2: Subcutaneous administration of purified pituitary gonadotropin at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met.

intervention 1: Gonalef® (Follitropin alfa) intervention 2: Purified pituitary gonadotropin (Fertinorm-P®)

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT01185782

[ 3 ]

480

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Diabetes Mellitus, Type 2

Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy

null

6

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

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

6

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

intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks intervention 5: Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 6: Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose intervention 6: Placebo

1

Okayama | N/A | Japan | 133.93333 | 34.65

0

NCT01263470

[ 3 ]

43

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.

null

Breast Cancer Metastatic Bone Disease

null

2

arm 1: Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. arm 2: Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.

[ 1, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Single ZA 4 mg IV infusion at the start of treatment intervention 2: Once-daily odanacatib 5 mg tablet for 4 weeks intervention 3: Once-daily odanacatib matching placebo for 4 weeks intervention 4: Single IV infusion of ZA matching placebo given at the start of treatment

intervention 1: ZA intervention 2: Odanacatib intervention 3: Odanacatib matching placebo intervention 4: ZA matching placebo

0

null

0

NCT00399802

[ 4 ]

129

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

null

ADHD

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day). intervention 2: Placebo

intervention 1: Vyvanse (lisdexamfetamine dimesylate) intervention 2: Placebo

9

0

NCT00500149