ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00487942
Conditions: Schizophrenia
Sponsor: Cephalon
Start date: 2007-07-01; Completion date: 2007-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed description:

Arms: 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.
Interventions: intervention 1: armodafinil intervention 2: armodafinil intervention 3: armodafinil intervention 4: placebo
Intervention descriptions: intervention 1: 50 mg/day armodafinil intervention 2: 100 mg/day armodafinil intervention 3: 200 mg/day armodafinil intervention 4: placebo

Protocol documents:
Clinical trial NCT00489424
Conditions: Osteoporosis
Keywords: zoledronic acid post dose symptoms transient acetaminophen fluvastatin
Sponsor: Novartis Pharmaceuticals
Start date: 2007-06-01; Completion date: 2007-12-01
Enrollment: 793 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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).
Interventions: intervention 1: Placebo intervention 2: Acetaminophen intervention 3: Fluvastatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00489476
Conditions: Migraine
Keywords: Staccato® Loxapine, Migraine
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2007-06-01; Completion date: 2007-12-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: 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
Interventions: intervention 1: Staccato Loxapine intervention 2: Staccato Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo aerosol inhalation (0mg)

Protocol documents:
Clinical trial NCT00490269
Conditions: Marijuana Dependence
Keywords: Marijuana dependence
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2006-10-01; Completion date: 2007-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Dronabinol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00501852
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Age≥40 yrs, Glycopyrronium Bromide
Sponsor: Novartis Pharmaceuticals
Start date: 2007-07-01; Completion date: 2007-12-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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

Detailed description:

Arms: 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.
Interventions: intervention 1: NVA237 intervention 2: Placebo intervention 3: Tiotropium
Intervention descriptions: intervention 1: single-dose dry-powder inhaler (SDDPI) intervention 2: single-dose dry-powder inhaler (SDDPI) intervention 3: Handihaler inhaler

Protocol documents:
Clinical trial NCT00523744
Conditions: Hypertension
Keywords: hypertension, valsartan, amlodipine
Sponsor: Novartis
Start date: 2007-07-01; Completion date: 2007-12-01
Enrollment: 257 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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).

Detailed description:
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

Arms: 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.
Interventions: intervention 1: Amlodipine intervention 2: Olmesartan medoxomil intervention 3: Amlodipine+valsartan intervention 4: Hydrochlorothiazide
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00543062
Conditions: Cardiotoxicity
Keywords: Inhaled prochlorperazine, Thorough Qt/QTc,
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2007-10-01; Completion date: 2007-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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

Detailed description:
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.

Arms: 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
Interventions: intervention 1: Inhaled placebo intervention 2: Oral placebo intervention 3: Inhaled prochlorperazine 5 mg intervention 4: Inhaled prochlorperazine 10 mg intervention 5: Oral moxifloxacin
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00564447
Conditions: Bacterial Infections Eye Infections
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-12-01; Completion date: 2007-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: Azithromycin intervention 2: Moxifloxacin
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00565084
Conditions: Osteoarthritis, Knee
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-03-01; Completion date: 2007-12-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: arm 1: Ibuprofen arm 2: Placebo 1 arm 3: Placebo 2
Interventions: intervention 1: ibuprofen intervention 2: Placebo
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00567840
Conditions: Pulmonary Tuberculosis
Keywords: Early Bactericidal Activity EBA pulmonary tuberculosis PA-824 Pretomanid CL-007
Sponsor: Global Alliance for TB Drug Development
Start date: 2007-08-01; Completion date: 2007-12-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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
Interventions: intervention 1: PA-824
Intervention descriptions: intervention 1: 200 mg, 600 mg, 100 mg, 1200 mg qd

Protocol documents:
Clinical trial NCT00593606
Conditions: Parkinson's Disease
Keywords: Rotigotine NEUPRO Switching trial from ropinirole to rotigotine, safety and tolerability Parkinson disease
Sponsor: UCB Pharma
Start date: 2007-07-01; Completion date: 2007-12-01
Enrollment: 124 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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

Detailed description:

Arms: 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.
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application

Protocol documents:
Clinical trial NCT00618995
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-08-01; Completion date: 2007-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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).

Detailed description:
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

Arms: 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
Interventions: intervention 1: Comparator: ER niacin (+) laropiprant intervention 2: Comparator: ER niacin intervention 3: Comparator: laropiprant intervention 4: Comparator: placebo
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00620425
Conditions: Healthy
Keywords: sumatriptan Intraject Local Site Reactions
Sponsor: Zogenix, Inc.
Start date: 2007-12-01; Completion date: 2007-12-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Interventions: intervention 1: Sumatriptan
Intervention descriptions: intervention 1: injection

Protocol documents:
Clinical trial NCT00684073
Conditions: Opiate-related Disorders Opiate Dependence Drug Abuse
Keywords: Suboxone Subutex Buprenorphine Naloxone
Sponsor: Indivior Inc.
Start date: 2007-07-01; Completion date: 2007-12-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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®.

Detailed description:

Arms: arm 1: Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Interventions: intervention 1: buprenorphine intervention 2: buprenorphine/naloxone
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00686127
Conditions: Neuropathic Pain Postmastectomy Pain
Keywords: breast cancer neuropathic pain topical lidocaine postmastectomy pain breast symptoms breast pain
Sponsor: University of California, San Francisco
Start date: 2003-09-01; Completion date: 2007-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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.
Interventions: intervention 1: Lidoderm patch intervention 2: Placebo patch
Intervention descriptions: 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.

Protocol documents: