ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02120924
Conditions: Rosacea
Keywords: Moderate facial rosacea Azelaic acid Rosacea
Sponsor: Actavis Inc.
Start date: 2013-07-01; Completion date: 2014-09-01
Enrollment: 1009 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of moderate facial rosacea.

Detailed description:
FINACEA® (azelaic acid) GEL, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing and antimicrobial action, although its mechanism of action in rosacea is not well understood. This study will be conducted in compliance with the protocol, Good Clinical Practices (GCP) and the applicable regulatory requirement(s). Marketed by Intendis, Finacea® (azelaic acid) Gel, 15% is a safe and effective topical therapy used for the treatment of moderate facial rosacea. Watson Laboratories, Inc. has developed a generic formulation of azelaic acid 15% gel and the current study is designed to evaluate the safety and efficacy of this formulation.

Arms: arm 1: Finacea® (azelaic acid) Gel, 15% (Intendis) arm 2: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.) arm 3: Gel Vehicle of the test product (Watson Laboratories, Inc.)
Interventions: intervention 1: Azelaic acid intervention 2: Vehicle intervention 3: Finacea
Intervention descriptions: intervention 1: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. intervention 2: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. intervention 3: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Protocol documents:
Clinical trial NCT02126670
Conditions: Actinic Keratosis
Sponsor: Promius Pharma, LLC
Start date: 2014-04-01; Completion date: 2014-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.

Detailed description:

Arms: arm 1: ACT01 Cream in combination with Comp01 Cream, once daily, 29 days arm 2: ACT01 Cream in combination with Comp02 Cream, once daily, 29 days arm 3: ACT01 Cream in combination with Comp03 Cream, once daily, 29 days arm 4: ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
Interventions: intervention 1: ACT01 intervention 2: Comp01 intervention 3: Comp02 intervention 4: Comp03 intervention 5: Comp04
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02129192
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-05-01; Completion date: 2014-09-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).

Detailed description:

Arms: arm 1: Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet arm 2: Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
Interventions: intervention 1: Amlodipine 5mg capsule intervention 2: T80/H12.5 mg FDC tablet intervention 3: T80/A5/H12.5 mg FDC tablet
Intervention descriptions: intervention 1: Amlodipine 5mg capsule intervention 2: Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet intervention 3: Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet

Protocol documents:
Clinical trial NCT02161731
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-06-01; Completion date: 2014-09-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
All study participants will receive both warfarin and a study drug called evacetrapib. The main purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of warfarin when given both with and without evacetrapib. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with evacetrapib by measuring the time it takes for blood to clot and comparing it to an average of the international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average.

The study will last approximately 5 weeks, not including screening.

Detailed description:

Arms: arm 1: 15 milligram (mg) warfarin administered as a single oral dose on Day 1 arm 2: Evacetrapib administered once daily (QD), orally, for 16 days with 15 mg warfarin co-administered once orally on Day 17
Interventions: intervention 1: Evacetrapib intervention 2: Warfarin
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration

Protocol documents:
Clinical trial NCT02196714
Conditions: COPD
Keywords: Japanese Healthy Volunteers
Sponsor: Pearl Therapeutics, Inc.
Start date: 2014-07-01; Completion date: 2014-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.

Detailed description:

Arms: arm 1: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID) arm 2: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID) arm 3: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID) arm 4: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
Interventions: intervention 1: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 intervention 2: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 intervention 3: Glycopyrronium (GP) Dose 1 intervention 4: Glycopyrronium (GP) Dose 2
Intervention descriptions: intervention 1: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID) intervention 2: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID) intervention 3: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID) intervention 4: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

Protocol documents:
Clinical trial NCT02198963
Conditions: Irritation/Irritant
Keywords: Skin irritation potential of RUT058-60.
Sponsor: Pulmatrix Inc.
Start date: 2014-07-01; Completion date: 2014-09-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the skin irritation potential of RUT058-60 after repetitive patch application to abraded and non-abraded skin of human subjects.

Detailed description:
This Cumulative Irritation Evaluation is designed to determine the skin irritation potential of RUT058-60, after repetitive patch application to abraded and non-abraded skin of healthy human subjects. Abraded skin will be challenged because the Test Product may be used, in practice, on non-intact skin. The primary research objective in this study is determine the skin irritation potential of RUT058-60. This question will be answered based on the observed results acquired evaluating its application to the abraded and non-abraded skin of at least 30 volunteer subjects, on the test product relative to the control readings.

A sufficient number of subjects will be recruited into the study to ensure 30 subjects, including both males and females, complete the study. Prior to the first application of test materials, designated skin sites will be abraded using the Tape Stripping Procedure. Occlusive patches will be used to apply approximately 0.02 mL of Test Product, Positive Control and Negative Control to abraded and non-abraded sites on the skin in the scapular region of each subject's back. The irritation potential of the test materials will be determined over the course of a 21-day challenge period on at least 30 subjects. A test material will be applied to the same site, abraded and non-abraded, on each day for 21 days. The six skin sites will be evaluated visually prior to each patch application and following the final patch removal.

Arms: arm 1: Occlusive patches will be used to apply approximately 0.02 mL of the Test Product RUT058-60 to abraded and non-abraded sites on the skin in the scapular region of each subject's back. arm 2: Occlusive patches will be used to apply approximately 0.02 mL of the Positive Control (0.1% Sodium Lauryl Sulfate) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days. arm 3: Occlusive patches will be used to apply approximately 0.02 mL of the Negative Control (0.9% Physiological Saline, USP) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.
Interventions: intervention 1: Hypochlorous acid solution 106 mg/L intervention 2: 0.1% (w/v) Sodium Lauryl Sulfate intervention 3: 0.9% Physiological Saline, USP
Intervention descriptions: intervention 1: test product intervention 2: positive control intervention 3: negative control

Protocol documents:
Clinical trial NCT02210247
Conditions: Healthy Volunteers
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2014-08-01; Completion date: 2014-09-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.

Detailed description:
During Dosing Period 1, blood samples for pharmacokinetic (PK) analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 12 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, and 12 hours) for Cohort 4; through 36 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, and 36 hours) for Cohort 3; through 60 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, and 60 hours) for Cohort 2; and through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours) for Cohorts 1 and 5.

During Dosing Period 2 (Cohorts 2, 3, and 4 only), blood samples for PK analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours).

Arms: arm 1: Cohort 1 will receive a single dose of EXPAREL 266 mg on Day 1. No additional dose will be given. arm 2: Cohort 2 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. arm 3: Cohort 3 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. arm 4: Cohort 4 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. arm 5: Cohort 5 will receive a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL).
Interventions: intervention 1: EXPAREL
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02217618
Conditions: Healthy Participants
Sponsor: Eli Lilly and Company
Start date: 2014-08-01; Completion date: 2014-09-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.

Detailed description:

Arms: arm 1: Single oral dose of 20 milligrams (mg) LY2409021.
Interventions: intervention 1: LY2409021
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02265224
Conditions: no Condition
Keywords: healthy volunteers
Sponsor: Zambon SpA
Start date: 2014-09-01; Completion date: 2014-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study primary Objective:

\- To evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of N-acetyl-cysteine 600 mg uncoated tablets vs. N-acetyl-cysteine 600 mg film-coated tablets (NAC) in healthy male and female volunteers.

Study secondary objectives:

* To describe the pharmacokinetic (PK) profile of NAC in plasma after single dose administration of NAC 600 mg uncoated tablets vs. NAC 600 mg film-coated tablets;
* to collect safety and tolerability data after single dose administration of NAC 600 mg uncoated tablets vs. NAC 600 mg film-coated tablets.

Detailed description:
This is single centre, single dose, open, randomised, cross-over, two-stage bioequivalence study to compare two different oral formulations of NAC.

The study has been conducted in healthy volunteers of both genders, in one single dose of both formulations.

The initial 48 subjects were sufficient to satisfy the study objectives on the basis of the ad interim preliminary bioequivalence test. The study was then considered as concluded and the second stage did not take place.

Arms: arm 1: N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose) followed by NAC 600 mg film-coated tablet (single dose) arm 2: N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose) followed by NAC 600 mg uncoated tablet (single dose)
Interventions: intervention 1: N-acetylcysteine
Intervention descriptions: intervention 1: The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.

Protocol documents:
Clinical trial NCT02267746
Conditions: Acne Vulgaris
Sponsor: Actavis Inc.
Start date: 2014-06-01; Completion date: 2014-09-01
Enrollment: 893 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.

Detailed description:
Although topical retinoids have been individually used to successfully treat acne vulgaris, Fabior™ (Tazarotene) Foam, 0.1% is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis has developed a generic formulation of Tazarotene Foam, 0.1%, and the current study is designed to evaluate the safety and efficacy of this formulation.

Arms: arm 1: Reference listed drug: Fabior™ 0.1% foam (Stiefel) arm 2: Tazarotene 0/1% foam (Actavis) arm 3: Foam vehicle of the test product (Actavis)
Interventions: intervention 1: Tazarotene (Fabior™) intervention 2: Tazarotene (Actavis) intervention 3: Vehicle foam
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02331940
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease sleeping oxygen saturation sleep quality
Sponsor: University of Crete
Start date: 2010-03-01; Completion date: 2014-09-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.

Detailed description:
Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension \>60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.

Arms: arm 1: Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler arm 2: Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
Interventions: intervention 1: tiotropium intervention 2: Handihaler intervention 3: Respimat
Intervention descriptions: intervention 1: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. intervention 2: Inhalation via the HandiHaler once daily intervention 3: Inhalation via the Respimat once daily

Protocol documents:
Clinical trial NCT02601976
Conditions: Hepatitis C
Keywords: PegInterferon alpha-2a Ribavirin Hepatitis C Virus Sustained Virological Response End of Treatment Response Unipeg Ribazole
Sponsor: Getz Pharma
Start date: 2010-08-01; Completion date: 2014-09-01
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hepatitis C is a global problem, prevalent in developed as well as in the developing countries. New treatment regimens using PegInterferon in combination with ribavirin has led to improved sustained viral response rates for some genotypes. A single arm, open labeled, multicentre trial was conducted to evaluate the response rate and safety of PegInterferon alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality of life at baseline and at follow-up visits were determined using SF-36.

Detailed description:
A multicenter, phase IV, open labeled, single arm study was conducted. Total 110 patients were screened for recruitment. Out of which 67 subjects met the inclusion criteria, 3 failed to give the informed consent and were excluded. The final sample size of the study was 64 patients. The duration of study was August 2010 to September 2013. Peginterferon alfa-2a 180µg 20kDa (Unipeg®) solution for injection was administered as single dose sub-cutaneous once weekly for 24 weeks to patients with genotype 3 and 48 weeks in patients with genotype 1 at the site of recruitment. Ribavirin (Ribazole) orally were given in divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). Quality of life related Physical Component Score (PCS) \& Mental Component Score (MCS) were measured through Health-Related Quality of Life (HRQOL) Questionnaire (SF-36). The SF-36 questionnaire was completed for all patients during their evaluations before treatment, at 4 weeks, at the end of treatment and at 24 weeks after completion of treatment.

Arms: arm 1: PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight
Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. intervention 2: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT02806544
Conditions: Breast Cancer Breast Neoplasms
Keywords: Breast neoplasms Breast cancer Locally advanced breast cancer Neoadjuvant endocrine therapy Tamoxifen Low and middle income country
Sponsor: Vanderbilt University
Start date: 2013-01-01; Completion date: 2014-09-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.

Detailed description:
This is a single arm feasibility study of neoadjuvant tamoxifen for locally advanced hormone receptor positive breast cancer in a low-resource setting in a middle-income country (Guatemala). Patients will be treated with tamoxifen for four to six weeks, then have an on-treatment biopsy to assess Ki-67. If Ki-67 is less than or equal to 10%, the patient will continue on tamoxifen for a total of 4 months; if Ki-67 is greater than 10% or there is clinical progression, patients will be taken off study. The study will evaluate the proportion of patients treated with four months of tamoxifen who undergo definitive surgery and the clinical and pathologic response rates.

Arms: arm 1: Tamoxifen 20mg by mouth daily
Interventions: intervention 1: Tamoxifen
Intervention descriptions: intervention 1: Tamoxifen 20mg by mouth daily

Protocol documents: