ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01860703
Conditions: Prolonged QTc Interval
Keywords: Ferriprox® LI DFP Deferiprone Healthy Volunteers
Sponsor: ApoPharma
Start date: 2012-11-01; Completion date: 2013-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover study to evaluate the effect of deferiprone on QTc prolongation after administration of a single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in healthy volunteers as compared to placebo treatment.

Detailed description:
Post-marketing study to evaluate the effect of deferiprone and deferiprone 3-O-glucuronide on QTc prolongation in healthy volunteers after administration of a single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral dose of deferiprone and moxifloxacin (Avelox®).

Arms: arm 1: Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets arm 2: Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets arm 3: Single dose of matching deferiprone and moxifloxacin placebo tablets. arm 4: Single dose of one 400 mg moxifloxacin tablet.
Interventions: intervention 1: Deferiprone intervention 2: deferiprone matching placebo tablets intervention 3: moxifloxacin intervention 4: placebo
Intervention descriptions: intervention 1: Ferriprox 500 mg tablets intervention 2: deferiprone matching placebo tablets intervention 3: Active control intervention 4: moxifloxacin-matching placebo

Protocol documents:
Clinical trial NCT01870388
Conditions: Liver Diseases Hepatic Insufficiency
Sponsor: Eli Lilly and Company
Start date: 2013-06-01; Completion date: 2013-07-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to measure how much of the study drug called baricitinib gets into the blood stream and how long it takes the body to get rid of it. Healthy participants and those with liver disease may enroll. The study will last about 7 days for each participant, not including screening.

Detailed description:

Arms: arm 1: Group 1: 4 milligrams (mg) baricitinib administered once, orally, to participants with normal hepatic function. arm 2: Group 2: 4 mg baricitinib administered once, orally, to participants with moderate hepatic impairment. arm 3: Group 3: 4 mg baricitinib administered once, orally, to participants with mild hepatic impairment. Enrollment is contingent on data from Groups 1 and 2.
Interventions: intervention 1: Baricitinib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01877642
Conditions: Healthy Volunteers
Keywords: ADASUVE inhaled loxapine drug drug interaction lorazepam acute treatment of agitation
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2013-06-01; Completion date: 2013-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.

Detailed description:
The objective of this study is to compare the safety and pharmacodynamic profiles of concomitant administration of a single dose of ADASUVE and lorazepam (IM) compared to that of each agent administered alone. Respiratory pharmacodynamics will be monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures will include effects on blood pressure, heart rate, sedation and psychomotor measures of attention, information processing speed, reaction time, and coordination.

Initially, 4 subjects will receive lorazepam 1 mg IM + ADASUVE 10 mg open label to validate the dose regimen. After the safety data are reviewed and the dose regimen confirmed, 18 non-obese, healthy male or female volunteers between the ages of 18 and 50 will be enrolled in this double-blinded, double-dummy, randomized, 3-period cross-over drug interaction study.

Arms: arm 1: Inhaled Staccato loxapine 10 mg + IM lorazepam 1 mg to confirm tolerability of combined treatment arm 2: Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg arm 3: Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg arm 4: Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg arm 5: Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg arm 6: Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg arm 7: Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
Interventions: intervention 1: Lorazepam 1 mg IM intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled Placebo intervention 4: Placebo IM
Intervention descriptions: intervention 1: Lorazepam 1 mg intramuscular intervention 2: Inhaled Staccato loxapine 10 mg intervention 3: Inhaler with no drug in it to mimic the ADASUVE inhaler intervention 4: intramuscular placebo to mimic lorazepam 1 mg IM

Protocol documents:
Clinical trial NCT01879371
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-06-01; Completion date: 2013-07-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate (Nurofen Immedia®).

Detailed description:

Arms: arm 1: film-coated tablet arm 2: film-coated tablet arm 3: fixed-dose-combination (FDC)
Interventions: intervention 1: Ibuprofen+caffeine FDC intervention 2: Ibuprofen (Nurofen Immedia®) intervention 3: Ibuprofen (Brufen®)
Intervention descriptions: intervention 1: oral dose intervention 2: oral dose intervention 3: oral dose

Protocol documents:
Clinical trial NCT01882062
Conditions: Huntington Disease
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Start date: 2013-05-01; Completion date: 2013-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this project is to study the efficacy of an anaplerotic treatment on brain energy profile evolution at an early stage of the Huntington disease.

Detailed description:

Arms: arm 1: All patients received Triheptanoin oil at 1g/kg/day during 1 month
Interventions: intervention 1: Triheptanoin 1g/kg/day
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02092961
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis OSKIRA fostamatinib CE-MRI DCE-MRI
Sponsor: AstraZeneca
Start date: 2011-02-01; Completion date: 2013-07-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative and more sensitive modalities for measuring the beneficial effects of syk inhibition with fostamatinib in patients with active RA. This MRI sub-study was reported later than the main study due to recruitment delays at specialist imaging sites and so is registered and presented entirely separately to the main study results.

This study will investigate the impact of treatment on joint activity and damage by assessing synovitis, osteitis, bone erosions and joint space narrowing.

Detailed description:
Sub-study to OSKIRA-4: A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study Date: 21 March 2011 Version: 1 Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by: - Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.

Arms: arm 1: Oral treatment and subcutaneous injection. arm 2: Oral treatment and subcutaneous injection. arm 3: Placebo bid for 6 weeks followed by switch to 100 mg fostamatinib bid for 24 weeks, plus placebo subcutaneous injection every 2 weeks.
Interventions: intervention 1: Fostamatinib intervention 2: Adalimumab intervention 3: Placebo of Fostamatinib intervention 4: Placebo of Adalimumab
Intervention descriptions: intervention 1: Fostamatinib 100mg twice daily. intervention 2: Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks. intervention 3: Placebo bid for 6 weeks. intervention 4: Placebo injection once every two weeks.

Protocol documents:
Clinical trial NCT04531813
Conditions: Hypersensitivity
Sponsor: Bayer
Start date: 2013-06-10; Completion date: 2013-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study researchers want to study the potential skin reaction after repeated application of an antifungal cream containing trolamine. The study plans to enroll about 32 healthy female or male participants with the age 18 - 79 years. Researchers will apply on the skin of the upper back between the shoulder blades of the study participants three different patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl sulfate, which is known to cause skin irritation (so called positive control). A third patch will cover a skin area without any product (so called negative control). Participants will return daily to the study center to have new patches containing the test products applied on the same skin area of the back, excluding weekends, for 21 days of continuous skin contact. At each visit the skin will be investigated by the researchers for redness, dryness and other reactions to learn about the skin reaction after repeated application.

Detailed description:

Arms: arm 1: Participants received butenafine HCl 1% cream on the skin test site, 0.3% solution of sodium lauryl sulfate on the skin Positive Control test site, and a blank patch on the skin Negative Control test site daily (excluding weekends) for 21 days, or 15 applications.
Interventions: intervention 1: Butenafine HCl 1% (BAY1896425) intervention 2: Positive Control-Sodium lauryl sulfate (SLS) intervention 3: Negative Control
Intervention descriptions: intervention 1: Approximately 0.2 g of cream containing butenafine HCl 1% daily (excluding weekends) was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the skin test site. The total dose applied to each participant completing the trial was 3 g. intervention 2: Approximately 0.2 mL of 0.3% solution of sodium lauryl sulfate was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the Positive Control test site. intervention 3: A blank patch was applied to the Negative Control test site.

Protocol documents:
Clinical trial NCT00171951
Conditions: Cushing Disease
Keywords: Cushing's disease ACTH Cortisol ACTH dependent Cushing's disease
Sponsor: Novartis Pharmaceuticals
Start date: 2004-08-13; Completion date: 2013-07-08
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and efficacy of pasireotide in participants with Cushing's disease.

Detailed description:

Arms: arm 1: Participants received pasireotide 600 micrograms (μg) twice daily (BID) subcutaneously (SC) to achieve or maintain urinary free cortisol (UFC) normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.
Interventions: intervention 1: Pasireotide
Intervention descriptions: intervention 1: Pasireotide 600 μg or 900 μg was administered as an SC injection.

Protocol documents:
Clinical trial NCT01769274
Conditions: Inherited Erythromelalgia
Sponsor: Pfizer
Start date: 2012-10-22; Completion date: 2013-07-12
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of single doses of PF-05089771 against placebo in treatment of pain in patients with primary, inherited erythromelalgia.

Detailed description:

Arms: arm 1: None arm 2: Single oral dose of placebo for PF-05089771 1600 mg
Interventions: intervention 1: PF-05089771 intervention 2: Placebo
Intervention descriptions: intervention 1: A single oral dose of PF-05089771 1600 mg solution to be administered on Day 1 of each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of PF-05089771 will be adminstered. intervention 2: Placebo for PF-05089771 1600 mg solution administered in each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of placebo will be administered.

Protocol documents:
Clinical trial NCT00611455
Conditions: Arthritis, Rheumatoid
Sponsor: GlaxoSmithKline
Start date: 2008-01-01; Completion date: 2013-07-15
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. the primary purpose of the study is to demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab.

Detailed description:
This study consists of a Double-blind , placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive ofatumumab (700mg x 2 infusions) or placebo ( saline x 2 infusions) in addition to their background methotrexate treatment. Patients who completed the 24 week Double-Blind period without receiving rescue DMARD treatment will be eligible to proceed into the 120 week Open-Label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity . Patients who have completed the Open-Label Period or have withdrawn will enter a maximum 2 year Follow-up Period, or until their Bcells return to normal or to baseline levels, whichever occurs earlier.

Arms: arm 1: 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period arm 2: 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period
Interventions: intervention 1: ofatumumab intervention 2: Placebo
Intervention descriptions: intervention 1: 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period intervention 2: 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Protocol documents:
Clinical trial NCT01470469
Conditions: Generalized Anxiety Disorder (GAD) Anxiety, Separation Phobia, Social
Sponsor: Shire
Start date: 2012-01-04; Completion date: 2013-07-15
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD503 (extended-release Guanfacine hydrochloride) intervention 2: Placebo
Intervention descriptions: intervention 1: Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance). intervention 2: Once-daily oral dosing in the evening for 12 weeks.

Protocol documents:
Clinical trial NCT01155479
Conditions: Parkinson Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-07-06; Completion date: 2013-07-16
Enrollment: 1022 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).

Detailed description:

Arms: arm 1: Preladenant 2 mg oral tablet and placebo for rasagiline taken in the morning (AM) followed by preladenant 2 mg oral tablet taken in the evening (PM) for 26 weeks (Part 1) and then for another 26 weeks (Part 2). arm 2: Preladenant 5 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 5 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). arm 3: Preladenant 10 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 10 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). arm 4: Placebo for preladenant and placebo for rasagiline taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2). arm 5: Rasagiline 1 mg oral capsule and placebo for preladenant taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Interventions: intervention 1: Preladenant 2 mg tablet intervention 2: Preladenant 5 mg tablet intervention 3: Preladenant 10 mg tablet intervention 4: Rasagiline 1 mg capsule intervention 5: Placebo for Rasagiline 1 mg capsule intervention 6: Placebo for Preladenant
Intervention descriptions: intervention 1: Preladenant 2 mg oral tablet taken twice daily intervention 2: Preladenant 5 mg oral tablet taken twice daily intervention 3: Preladenant 10 mg oral tablet taken twice daily intervention 4: Rasagiline 1 mg oral capsule taken once daily intervention 5: Placebo for rasagiline 1 mg oral capsule taken once daily intervention 6: Placebo for preladenant 2 mg, 5 mg, or 10 mg oral tablet taken twice daily

Protocol documents:
Clinical trial NCT01841112
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-04-22; Completion date: 2013-07-18
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Detailed description:

Arms: arm 1: Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment arm 2: Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 arm 3: Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 arm 4: Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 arm 5: Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first does of multipled dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
Interventions: intervention 1: Placebo intervention 2: BI-409306 25 milligram (mg) SD intervention 3: BI-409306 50 mg SD intervention 4: BI-409306 100 mg SD intervention 5: BI-409306 100 mg MD
Intervention descriptions: intervention 1: Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment intervention 2: Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 intervention 3: Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 intervention 4: Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 intervention 5: Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

Protocol documents:
Clinical trial NCT01177540
Conditions: Pediatric Acute Myelogenous Leukemia (AML)
Sponsor: Eisai Inc.
Start date: 2011-03-03; Completion date: 2013-07-19
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Decitabine intervention 2: Decitabine
Intervention descriptions: intervention 1: 5 day priming with decitabine followed by Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide). intervention 2: Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide) only

Protocol documents: