ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00165672
Conditions: Non-erosive Gastroesophageal Reflux Disease
Keywords: 24-hour esophageal pH monitoring non-erosive gastroesophageal reflux disease NERD proton pump inhibitor rabeprazole
Sponsor: Eisai Inc.
Start date: 2005-05-01; Completion date: 2005-10-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: RABEPRAZOLE SODIUM intervention 2: RABEPRAZOLE SODIUM
Intervention descriptions: intervention 1: rabeprazole sodium 5 mg: once daily orally for 4 weeks intervention 2: rabeprazole sodium 10 mg: once daily orally for 4 weeks

Protocol documents:
Clinical trial NCT00244842
Conditions: Psoriasis
Keywords: Randomized Controlled Trials Immunosuppression Adult Chronic Disease Dermatologic Agents Female Humans Male Middle Aged Severity of Illness Index Treatment Outcome Quality of Life Double-Blind Method
Sponsor: Aurinia Pharmaceuticals Inc.
Start date: 2004-12-01; Completion date: 2005-10-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.

Detailed description:
Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.

Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.

Arms: arm 1: Placebo arm 2: Voclosporin 0.2 mg/kg po BID arm 3: Voclosporin 0.3 mg/kg po BID arm 4: Voclosporin 0.4 mg/kg po BID
Interventions: intervention 1: voclosporin intervention 2: Placebo
Intervention descriptions: intervention 1: voclosporin 0.2, 0.3, or 0.4 mg/kg po BID intervention 2: Placebo

Protocol documents:
Clinical trial NCT00610428
Conditions: Migraine Headache, With or Without Aura
Keywords: Migraine, Staccato Prochlorperazine Migraine headache with or without aura.
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2005-03-01; Completion date: 2005-10-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Development of Staccato Prochlorperazine for the treatment of migraine headache.

Detailed description:

Arms: arm 1: Inhaled Staccato Placebo arm 2: Inhaled Staccato Prochlorperazine 5 mg arm 3: Inhaled Staccato Prochlorperazine 10 mg
Interventions: intervention 1: Staccato Placebo intervention 2: Staccato Prochlorperazine 5 mg intervention 3: Staccato Prochlorperazine 10 mg
Intervention descriptions: intervention 1: Inhaled Staccato Placebo intervention 2: Inhaled Prochlorperazine 5 mg intervention 3: Inhaled Prochlorperazine10 mg

Protocol documents:
Clinical trial NCT00678795
Conditions: Detrusor Overactivity Multiple Sclerosis
Keywords: Detrusor overactivity Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2002-08-01; Completion date: 2005-10-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.

Detailed description:
This is a ten week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex® on urge incontinence associated with neurogenic unstable bladder. Multiple sclerosis patients with incontinence symptoms are screened to determine eligibility and complete a two-week baseline period. They then return for a further eligibility check, randomisation and initial dosing. Subjects titrate and self-medicate with study medication between study visits at weeks two and five. They will also complete efficacy assessments in their diary-books and at visits.

Arms: arm 1: Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period. arm 2: Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Interventions: intervention 1: Sativex® intervention 2: Placebo
Intervention descriptions: intervention 1: Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L.

Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours intervention 2: containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.

Protocol documents:
Clinical trial NCT00779116
Conditions: Allergies
Sponsor: Organon and Co
Start date: 2005-09-01; Completion date: 2005-10-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg

Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a "smile" face scale.

Detailed description:

Arms: arm 1: Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. arm 2: Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.
Interventions: intervention 1: Desloratadine intervention 2: Zyrtec® (cetirizine)
Intervention descriptions: intervention 1: SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day intervention 2: Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day

Protocol documents:
Clinical trial NCT00780403
Conditions: Allergies
Sponsor: Organon and Co
Start date: 2005-08-01; Completion date: 2005-10-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets

Detailed description:

Arms: arm 1: Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. arm 2: Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.
Interventions: intervention 1: Desloratadine intervention 2: Zyrtec® (cetirizine)
Intervention descriptions: intervention 1: desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day intervention 2: Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day

Protocol documents:
Clinical trial NCT01183390
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2005-09-01; Completion date: 2005-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Anastrozole 1 mg Tablets arm 2: Arimidex® 1 mg Tablets
Interventions: intervention 1: Anastrozole intervention 2: Anastrozole
Intervention descriptions: intervention 1: 1 mg Tablets intervention 2: 1 mg Tablets

Protocol documents:
Clinical trial NCT00150592
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Shire
Start date: 2005-05-12; Completion date: 2005-10-05
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD503 (Guanfacine HCl) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00053677
Conditions: Gambling
Keywords: Impulse Control Disorders
Sponsor: University of Chicago
Start date: 2002-12-01; Completion date: 2005-11-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.

Detailed description:
PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe urges. The implications of this study extend from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and possibly alcoholism.

Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The responses of men and women are compared to determine whether efficacy is distributed in a male:female ratio analogous to that of the PGD population in the United States. A Clinical Global Impression and a Gambling Symptom Scale are used to assess participants.

Arms: arm 1: 17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses. arm 2: Subjects who were assigned to placebo in the 17 week double-blind phase.
Interventions: intervention 1: Naltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day. intervention 2: For subjects who were randomly assigned to placebo.

Protocol documents:
Clinical trial NCT00086281
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Sleep-disordered breathing Obstructive sleep apnea syndrome
Sponsor: Jazz Pharmaceuticals
Start date: 2003-11-01; Completion date: 2005-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

Detailed description:
This study will be conducted as a randomized, crossover study of the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

Arms: arm 1: Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later arm 2: Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. arm 3: Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). arm 4: Placebo was given at bedtime and again 2.5 to 4 hours later.
Interventions: intervention 1: Xyrem (X) intervention 2: Zolpidem (Z) intervention 3: Modafinil (M) intervention 4: Placebo (P)
Intervention descriptions: intervention 1: Xyrem (Sodium Oxybate) Oral Solution intervention 2: Zolpidem 10 mg oral tablets intervention 3: Modafinil Oral Tablets intervention 4: Placebo Oral Solution

Protocol documents:
Clinical trial NCT00086502
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-06-01; Completion date: 2005-11-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg arm 2: Placebo
Interventions: intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone intervention 4: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24 intervention 2: Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24 intervention 3: Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8 intervention 4: Metformin rescue for patients meeting

pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Protocol documents:
Clinical trial NCT00132769
Conditions: Rheumatoid Arthritis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-01-01; Completion date: 2005-11-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.

Detailed description:

Arms: arm 1: MK-0873 1.25 mg twice daily for 12 weeks arm 2: Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
Interventions: intervention 1: MK-0873 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: MK-0873 1.25 mg twice daily for 12 weeks intervention 2: Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00231777
Conditions: Post-Operative Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-07-01; Completion date: 2005-11-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. This new medication is being compared to another intravenous medication that is already available to patients for this indication.

Detailed description:

Arms: arm 1: 40 mg MK0517 IV arm 2: 4 mg ondansetron IV
Interventions: intervention 1: Comparator: MK0517 intervention 2: Comparator: ondansetron
Intervention descriptions: intervention 1: a single administration of 40 mg MK0517 by IV immediately prior to surgery intervention 2: a single administration of 4 mg ondansetron by IV immediately prior to surgery

Protocol documents:
Clinical trial NCT00703924
Conditions: Cutaneous Leishmaniasis
Keywords: cutaneous leishmaniasis topical treatment safety efficacy
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2003-03-01; Completion date: 2005-11-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

Detailed description:
WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects. Subjects will be randomized to receive either WR 279,396 or vehicle placebo; applied twice a day for 20 days.

Arms: arm 1: WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin arm 2: Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Interventions: intervention 1: WR 279,396 intervention 2: Placebo
Intervention descriptions: intervention 1: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion intervention 2: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

Protocol documents:
Clinical trial NCT00895232
Conditions: Restless Legs Syndrome
Sponsor: American Regent, Inc.
Start date: 2003-11-01; Completion date: 2005-11-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over four to six hours on two separate dates, separated by two to seven days. The third cohort received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within 30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.

Detailed description:

Arms: arm 1: 500 mg dose Venofer over 4 hours arm 2: 500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 arm 3: 500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours
Interventions: intervention 1: Cohort I intervention 2: Cohort II intervention 3: Cohort III
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01075971
Conditions: Opioid Dependency
Keywords: Buprenorphine tablet Fast dissolving tablet Opioid dependant patients
Sponsor: Indivior Inc.
Start date: 2005-09-01; Completion date: 2005-11-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy.

The objectives of this study are to evaluate the overall preference between two buprenorphine sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily maintenance therapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Buprenorphine hydrochloride marketed sublingual tablet (Subutex) intervention 2: Buprenorphine hydrochloride fast dissolving tablet (FDT)
Intervention descriptions: intervention 1: 8 mg or 16 mg daily, sublingual route on Days 1 and 2 intervention 2: 8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5

Protocol documents:
Clinical trial NCT00071812
Conditions: Arthritis, Rheumatoid
Keywords: RA
Sponsor: Human Genome Sciences Inc.
Start date: 2003-12-01; Completion date: 2005-12-01
Enrollment: 283 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).

Detailed description:
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 4 mg/kg intervention 4: Belimumab 10 mg/kg
Intervention descriptions: intervention 1: Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks. intervention 2: Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 3: Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 4: Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.

Protocol documents: