ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02121002
Conditions: Osteoarthritis
Keywords: Knee
Sponsor: Amneal Pharmaceuticals, LLC
Start date: 2014-04-01; Completion date: 2014-12-01
Enrollment: 1176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.

Detailed description:

Arms: arm 1: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks arm 2: Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks arm 3: Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Interventions: intervention 1: Diclofenac Sodium Topical Gel, 1% intervention 2: Voltaren Topical Gel, 1% intervention 3: Vehicle Diclofenac Sodium Topical Gel
Intervention descriptions: intervention 1: Opaque, white gel intervention 2: Opaque, white gel intervention 3: Opaque, white gel

Protocol documents:
Clinical trial NCT02121834
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This study will evaluate the safety and how well the body tolerates LY3050258. It will last approximately 14 weeks with a 2 week follow-up appointment after the last treatment with study drug.

Detailed description:

Arms: arm 1: Daily dose of LY3050258 for 28 days: Cohort A 10 mg, Cohort B 30 mg, Cohort C 90 mg, Cohort D 180 mg and Cohort E 360 mg. arm 2: Daily dose of placebo matching LY3050258 for 28 days.
Interventions: intervention 1: LY3050258 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02131636
Conditions: Erythema Rosacea
Sponsor: Allergan
Start date: 2014-05-01; Completion date: 2014-12-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Detailed description:

Arms: arm 1: AGN-199201 applied to the face once daily for 29 days. arm 2: Vehicle to AGN-199201 applied to the face once daily for 29 days.
Interventions: intervention 1: AGN-199201 intervention 2: Vehicle to AGN-199201
Intervention descriptions: intervention 1: AGN-199201 applied to the face once daily for 29 days. intervention 2: Vehicle to AGN-199201 applied to the face once daily for 29 days.

Protocol documents:
Clinical trial NCT02144155
Conditions: Schizophrenia
Keywords: Oxytocin
Sponsor: University of California, San Diego
Start date: 2012-03-01; Completion date: 2014-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.

Detailed description:
Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.

Arms: arm 1: Oxytocin twice daily for 3 weeks arm 2: Placebo for 3 weeks
Interventions: intervention 1: Oxytocin: 24IU - 168 IU intervention 2: Placebo
Intervention descriptions: intervention 1: Oxytocin: 24IU - 168 IU intervention 2: placebo drug

Protocol documents:
Clinical trial NCT02150499
Conditions: Asthma
Keywords: Acute Asthma exacerbation
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.

Detailed description:
This is a study to determine the safety and tolerability of cumulative dosing with levalbuterol tartrate HFA inhalation aerosol MDI using a valved holding chamber and facemask in pediatric subjects birth to ≤ 48 months of age with acute bronchospasm. It is a randomized, double-blind, parallel-group, multicenter, trial of 3 doses of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who present to either the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.

Eligible subjects whose parent(s) or legal guardian(s) provide written informed consent to participate will be randomized to 1 of 2 treatments. Treatment 1 consists of 3 doses, with each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA \[cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol\]); Treatment 2 consists of 3 doses, with each dose comprised of 8 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff \[cumulative dose of 1080 mcg of levalbuterol tartrate HFA inhalation aerosol\]). For each Treatment, study medication will be administered every 20 minutes over a period of 1 hour for three doses.

Arms: arm 1: Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol arm 2: Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
Interventions: intervention 1: levalbuterol tartrate HFA inhalation aerosol intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02152384
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will look into how a base dose of insulin peglispro and insulin glargine will affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.

Detailed description:

Arms: arm 1: Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required arm 2: Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required
Interventions: intervention 1: Insulin Peglispro intervention 2: Insulin Lispro intervention 3: Insulin Glargine
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: Administered SC

Protocol documents:
Clinical trial NCT02156492
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to investigate how the body responds to evacetrapib and to evaluate the safety and the effect of evacetrapib, alone and in combination with selected statins, in healthy Chinese participants. The study has 2 parts. Part one will last up to 4 weeks and part two will last up to 5 weeks, not including screening. Participants may only enroll in one part.

Detailed description:

Arms: arm 1: Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib. arm 2: Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib for 14 days. arm 3: Part 2, Cohorts B, Participants will receive simvastatin orally, once daily on Days 1 - 4. arm 4: Part 2, Cohorts B, Participants will receive evacetrapib orally once daily on Days 5 - 14 and simvastatin orally, once daily on Days 15 - 22. arm 5: Part 2, Cohorts C, Participants will receive atorvastatin orally, once daily on Days 1 - 4. arm 6: Part 2, Cohorts C, Participants will receive evacetrapib orally once daily on Days 5 - 14 and atorvastatin orally, once daily on Days 15 - 22.
Interventions: intervention 1: Evacetrapib intervention 2: Simvastatin intervention 3: Atorvastatin
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered orally. intervention 3: Administered orally.

Protocol documents:
Clinical trial NCT02160626
Conditions: Seborrheic Keratosis
Keywords: Seborrheic keratosis A101
Sponsor: Aclaris Therapeutics, Inc.
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

Detailed description:
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

Each subject will have 4 target lesions on the trunk/extremities.

A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.

Arms: arm 1: A-101 Vehicle (placebo) Topical Solution arm 2: A-101 (40) Topical Solution - high dose arm 3: A-101 (32.5) Topical Solution - low dose
Interventions: intervention 1: A-101 Vehicle intervention 2: A-101 (40) Topical Solution intervention 3: A-101 (32.5) Topical Solution
Intervention descriptions: intervention 1: Placebo control intervention 2: A-101 (40) Topical Solution - high dose intervention 3: A-101 (32.5) Topical Solution - low dose

Protocol documents:
Clinical trial NCT02169115
Conditions: Symptomatic Dermographism
Sponsor: Charite University, Berlin, Germany
Start date: 2012-12-01; Completion date: 2014-12-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Urticaria is a very frequent skin condition characterized by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms, which either occur spontaneously, i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia (also known as dermographic urticaria and symptomatic dermographism) is characterized by whealing and itching following a minor stroking pressure, rubbing or scratching of the skin. The majority of patients with urticaria factitia benefits from treatment with nonsedating antihistamines. Some patients, however, do not achieve adequate symptom control even with updosing of antihistamines and may suffer from substantial quality of life impairment . Since even very minor stroking of the skin can lead to the development of wheals and severe itching, these patients are for example limited in their choice of clothing and are impaired in their social interaction and partnership.

In all patients with a history of wheals after stroking of the skin, a provocation test should be performed. This can be done by stroking of the skin lightly with a smooth blunt object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the smooth blunt object should be held perpendicular to the skin and should be used to apply a light stroking pressure to the skin of the upper back or volar forearm. The reaction is considered positive in patients who show a weal response and report pruritus at the site of provocation.

Patients with a positive test reaction should be evaluated for individual pressure thresholds. For this purpose a provocation device (FricTest) has been developed that allows for reproducible and standardized threshold testing. Threshold testing enables physicians to assess disease severity and treatment response more precisely.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Omalizumab intervention 2: Omalizumab intervention 3: Placebo
Intervention descriptions: intervention 1: 150mg, s.c., every 4 weeks intervention 2: 300mg, s.c., every 4 weeks intervention 3: Placebo, s.c., every 4 weeks

Protocol documents:
Clinical trial NCT02170220
Conditions: Severe Hepatic Impairment
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy participants.

Detailed description:
The drug being tested in this study is called vortioxetine. Vortioxetine is being tested to assess how it moves throughout the body in people with severe hepatic impairment compared to people with normal hepatic function. This study looked at lab results in people who took vortioxetine.

The study enrolled 12 participants. Participants were assigned to one of the two treatment groups based on their hepatic function (severe hepatic impairment vs. normal hepatic function). All participants in both groups will receive one vortioxetine 5-mg tablet.

This single-center trial was conducted in the United States. The overall time to participate in this study was up to 58 days. Participants made 2 visits to the clinic, including one 12-day period of confinement to the clinic, and were contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function. arm 2: Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
Interventions: intervention 1: Vortioxetine
Intervention descriptions: intervention 1: Vortioxetine tablets

Protocol documents:
Clinical trial NCT02173392
Conditions: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2014-09-01; Completion date: 2014-12-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab

Detailed description:
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)

Arms: arm 1: A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection arm 2: A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Interventions: intervention 1: Brodalumab
Intervention descriptions: intervention 1: Brodalumab is a large molecule for the treatment of inflammatory diseases

Protocol documents:
Clinical trial NCT02176005
Conditions: Healthy
Sponsor: Da Volterra
Start date: 2014-03-01; Completion date: 2014-12-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

Detailed description:
The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:

* To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.
* To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.

In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.

The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.

Arms: arm 1: Moxifloxacin, oral tablets, 400mg/day, once daily 5 days arm 2: Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days arm 3: DAV132 oral, 7.5g x3/day for 7 days arm 4: Negative control: 7.5g x3/day for 7 days
Interventions: intervention 1: DAV132 intervention 2: Moxifloxacin intervention 3: Negative Control
Intervention descriptions: intervention 1: DAV132 is associated to moxifloxacin or it is evaluated alone intervention 2: Moxifloxacin is used alone or associated to DAV132 intervention 3: Moxifloxacin is used alone

Protocol documents:
Clinical trial NCT02187029
Conditions: Gout
Keywords: Hyperuricemia gout serum uric acid
Sponsor: Pfizer
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF-06743649 intervention 2: Placebo intervention 3: PF-06743649 intervention 4: Placebo
Intervention descriptions: intervention 1: Daily dosing (dose level 1) tablet for 14 days intervention 2: Daily dosing (tablet) for 14 days intervention 3: Daily dosing (dose level 2) tablet(s) for 14 days intervention 4: Daily dosing (tablets) for 14 days

Protocol documents:
Clinical trial NCT02188303
Conditions: Healthy Volunteers
Sponsor: OPKO Health, Inc.
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese participants. Participation is expected to last up to about 7 weeks, not including screening.

Part B of the study will investigate the safety and tolerability of multiple doses of LY2944876 in non Japanese participants. Participation is expected to last up to about 8 weeks, not including screening.

All doses will be administered as injections into the fatty layer just beneath the skin.

Screening is required within 28 days prior to the start of the study. All participants will attend a post study safety assessment approximately 6 weeks after their final dose.

Detailed description:

Arms: arm 1: Single dose of placebo matching LY2944876 administered subcutaneous (SC) on Day 1 arm 2: Single dose of 10 milligrams (mg) of LY2944876 administered SC on Day 1 arm 3: Placebo matching LY2944876 administered once daily SC on Days 1-7 arm 4: 40 mg LY2944876 administered once daily SC on Days 1-7 arm 5: Placebo matching LY2944876 administered once daily SC on Days 1, 4, 6, 8, 10 and 12 arm 6: LY2944876 in titrated doses of 15 mg on Day 1, 30 mg on Day 4, up to 60 mg on Day 6, and up to 80 mg on Days 8, 10 and 12 administered once daily SC
Interventions: intervention 1: LY2944876 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC

Protocol documents:
Clinical trial NCT02192814
Conditions: Epilepsy Partial-onset Seizures
Keywords: Lacosamide LCM Epilepsy Partial-onset seizures iv
Sponsor: UCB Japan Co. Ltd.
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.

Detailed description:

Arms: arm 1: On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.

During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.

The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).
Interventions: intervention 1: Lacosamide (200 mg/20 mL)
Intervention descriptions: intervention 1: Active Substance: Lacosamide

Pharmaceutical form: Solution for intravenous (iv) infusion

Concentration: adapted on concentration of oral dose in EP0009

Route of Administration: Drip infusion

Protocol documents:
Clinical trial NCT02195986
Conditions: Atrophic Vaginitis
Keywords: vaginal dryness vaginal and/or vulvar irritation/itching dysuria vaginal pain and bleeding associated with sexual activity vaginal atrophy
Sponsor: Mylan Pharmaceuticals Inc
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

Detailed description:

Arms: arm 1: Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. arm 2: Estrace® 0.01% vaginal cream, administered once daily for 7 days. arm 3: Placebo Vaginal Cream, administered once daily for 7 days.
Interventions: intervention 1: Estradiol Vaginal Cream, 0.01% intervention 2: Estrace® 0.01% cream intervention 3: Placebo Vaginal Cream
Intervention descriptions: intervention 1: Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days) intervention 2: Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days) intervention 3: Placebo Vaginal Cream ( 1 x 2 g for 7 days)

Protocol documents: