ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01983111
Conditions: Pain
Sponsor: Mundipharma Korea Ltd
Start date: 2013-10-01; Completion date: 2014-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.

Detailed description:

Arms: arm 1: Patch arm 2: Oral tablet
Interventions: intervention 1: buprenorphine intervention 2: tramadol/acetaminophen
Intervention descriptions: intervention 1: Dosage and administration: This one patch should be attached every 7 days. intervention 2: Amount of drug ingredients

: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.

Dosage and administration:

Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.

Protocol documents:
Clinical trial NCT01993823
Conditions: Otomycosis
Sponsor: Salvat
Start date: 2013-05-01; Completion date: 2014-11-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis

Detailed description:

Arms: arm 1: Five drops into the ear canal twice daily for 14 days arm 2: Five drops into the ear canal twice daily for 14 days
Interventions: intervention 1: G238 intervention 2: Clotrimazole
Intervention descriptions: intervention 1: Five drops into the ear canal twice daily for 14 days intervention 2: Five drops into the ear canal twice daily for 14 days

Protocol documents:
Clinical trial NCT02006732
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2013-11-01; Completion date: 2014-11-01
Enrollment: 809 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

Detailed description:

Arms: arm 1: Once daily 2 puffs solution for inhalation Respimat arm 2: Once daily 2 puffs solution for inhalation Respimat arm 3: Once daily 2 puffs solution for inhalation Respimat arm 4: Once daily 2 puffs solution for inhalation Respimat
Interventions: intervention 1: olodaterol intervention 2: tiotropium intervention 3: placebo
Intervention descriptions: intervention 1: fixed dose combination intervention 2: fixed dose combination intervention 3: None

Protocol documents:
Clinical trial NCT02008682
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-12-01; Completion date: 2014-11-01
Enrollment: 368 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible subjects will continue their metformin background treatment during the trial.

Detailed description:

Arms: arm 1: 2-week screening period, 26-week treatment duration, and a 1-week follow-up period arm 2: 2-week screening period, 26-week treatment duration, and a 1-week follow-up period
Interventions: intervention 1: liraglutide intervention 2: sitagliptin
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose. intervention 2: Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.

Protocol documents:
Clinical trial NCT02014051
Conditions: Myelodysplastic Syndrome
Sponsor: SymBio Pharmaceuticals
Start date: 2013-03-01; Completion date: 2014-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate tolerability when SyB C-1101 is orally administered twice daily for 14 consecutive days to the patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be investigated.

Detailed description:
In Cohort 1, SyB C-1101 280 mg/dose group, Participants will be administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.

In Cohort 2, SyB C-1101 560 mg/dose group, Participants will be administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.

In both Cohorts, the treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles. The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.

Arms: arm 1: None
Interventions: intervention 1: SyB C-1101
Intervention descriptions: intervention 1: SyB C-1101（rigosertib sodium） will be administered to two cohorts at either 280 mg/day or 560 mg/day.

The dose will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days (14 days of administration + 7 days of observation) constitutes 1 cycle.

The study will involve treatment through the second cycle, but treatment can be continued for 3 or more cycles if conditions for continued administration are satisfied. However, treatment will be limited to a maximum of 6 cycles including the first cycle.

Protocol documents:
Clinical trial NCT02041221
Conditions: Asthma
Keywords: pharmacokinetics, pharmacodynamics, asthma
Sponsor: Sun Pharma Advanced Research Company Limited
Start date: 2014-01-01; Completion date: 2014-11-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.

Detailed description:

Arms: arm 1: Subjects will be administered with SPARC1316 dose 1 arm 2: The subjects will receive placebo. arm 3: Subjects will be administered with SPARC1316 dose 2 arm 4: Subjects will be administered with SPARC1316 dose 3 arm 5: Subjects will be administered with SPARC1316 dose 4 arm 6: Subjects will be administered with SPARC1316 dose 5
Interventions: intervention 1: SPARC1316 Dose 1 intervention 2: Placebo intervention 3: SPARC1316 Dose 2 intervention 4: SPARC1316 Dose 3 intervention 5: SPARC1316 Dose 4 intervention 6: SPARC1316 Dose 5
Intervention descriptions: intervention 1: The subjects will receive SPARC1316. intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02044874
Conditions: Smoking Cessation
Sponsor: Arena Pharmaceuticals
Start date: 2014-03-01; Completion date: 2014-11-01
Enrollment: 603 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.

Detailed description:

Arms: arm 1: APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks arm 2: APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks arm 3: Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Interventions: intervention 1: APD356-lorcaserin hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02045277
Conditions: Plaque Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2014-02-01; Completion date: 2014-11-01
Enrollment: 212 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The objective of the study is to evaluate the safety and efficacy of a topical lotion

Detailed description:
The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Arms: arm 1: halobetasol propionate \[HP\], tazarotene \[Taz\] arm 2: HP arm 3: Taz arm 4: Vehicle
Interventions: intervention 1: IDP-118 Lotion intervention 2: IDP-118 Monad HP Lotion intervention 3: IDP-118 Monad Taz Lotion intervention 4: IDP-118 Vehicle Lotion
Intervention descriptions: intervention 1: Lotion intervention 2: Active Comparator intervention 3: Active Comparator intervention 4: Vehicle

Protocol documents:
Clinical trial NCT02062905
Conditions: Chronic Allergic Conjunctivitis
Sponsor: Ocular Therapeutix, Inc.
Start date: 2014-03-01; Completion date: 2014-11-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Detailed description:

Arms: arm 1: OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use arm 2: PV (placebo drug delivery vehicle)
Interventions: intervention 1: Dexamethasone intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02063230
Conditions: Solid Tumors
Keywords: Phase I, healthy, pharmacokinetic, hepatic impairment
Sponsor: AstraZeneca
Start date: 2014-03-01; Completion date: 2014-11-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Detailed description:
An open label study to assess the pharmcokinetics, safety and tolerability of a single dose of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Arms: arm 1: Healthy volunteers (HV) arm 2: Mild (Child Pugh A) hepatic impaired patients arm 3: Moderate (Child Pugh B) hepatic impaired patients arm 4: Severe (Child Pugh C) hepatic impairment patients
Interventions: intervention 1: Selumetinib 50mg intervention 2: Selumetinib 25mg
Intervention descriptions: intervention 1: HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1 intervention 2: Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1

Protocol documents:
Clinical trial NCT02064985
Conditions: Stable Coronary Heart Disease (CHD)
Sponsor: AstraZeneca
Start date: 2014-02-01; Completion date: 2014-11-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese patients with stable coronary heart disease

Detailed description:
Up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.Ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. Following an 8 hour fast on single dose on Day 1 and Day 7; on multiple doses from Day 3 to Day 6. Prior to the first dose of study drug there will be a screening period of maximum of 19 days. Patients will report to the clinical pharmacology unit (CPU) on Day -2 and will remain confined there until completion of study procedures on Day 7, the patients will be discharged on Day 8. In addition, patients will return to the CPU for a follow up visit 2 to 5 days after the last dose. Each patients participation, including the screening period, will take approximately 33 days.

Arms: arm 1: A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7. arm 2: A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7. arm 3: A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
Interventions: intervention 1: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)
Intervention descriptions: intervention 1: To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).

Protocol documents:
Clinical trial NCT02081014
Conditions: Hypoglycemia
Keywords: Hypoglycemia Glucagon Diabetes
Sponsor: Xeris Pharmaceuticals
Start date: 2014-03-01; Completion date: 2014-11-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.

Detailed description:

Arms: arm 1: G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart arm 2: G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart arm 3: G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
Interventions: intervention 1: G-Pen Mini™ (glucagon injection)
Intervention descriptions: intervention 1: stable, pre-mixed, liquid glucagon for subcutaneous injection

Protocol documents:
Clinical trial NCT02081534
Conditions: Hyperphosphatemia
Keywords: S-phosphate, hyperphosphatemia, hemodialysis, ESRD
Sponsor: Ardelyx
Start date: 2014-03-01; Completion date: 2014-11-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period

Detailed description:
The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.

The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.

There are 7 parallel treatment arms in the study with bid and od treatment regimens.

Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.

The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.

Arms: arm 1: 1 mg AZD1722 bid arm 2: 3 mg AZD1722 bid arm 3: 10 mg AZD1722 bid arm 4: 30 mg AZD1722 bid arm 5: 3 mg AZD1722 od arm 6: 30 mg AZD1722 od arm 7: Placebo (double dummy technique)
Interventions: intervention 1: AZD1722 intervention 2: Placebo
Intervention descriptions: intervention 1: AZD1722, oral tablet intervention 2: Placebo bid, double dummy technique

Protocol documents:
Clinical trial NCT02096081
Conditions: Glabellar Frown Lines
Keywords: Glabellar Frown Lines Frown Lines Facial Wrinkles
Sponsor: Merz North America, Inc.
Start date: 2014-02-01; Completion date: 2014-11-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).

Detailed description:
This is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA (Botox®) in the treatment of glabellar frown lines.

Arms: arm 1: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points arm 2: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Interventions: intervention 1: IncobotulinumtoxinA intervention 2: OnabotulinumtoxinA
Intervention descriptions: intervention 1: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection intervention 2: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection

Protocol documents:
Clinical trial NCT02109562
Conditions: Schizophrenia
Keywords: Schizophrenia Schizophrenic Schizophrenias Risperidone
Sponsor: Indivior Inc.
Start date: 2014-04-01; Completion date: 2014-11-01
Enrollment: 354 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with placebo in the treatment of patients with schizophrenia.

This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses of RBP-7000 compared with placebo over an 8-week treatment period.

Detailed description:

Arms: arm 1: Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections. arm 2: Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections. arm 3: Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.
Interventions: intervention 1: RBP-7000 intervention 2: Placebo intervention 3: Risperidone
Intervention descriptions: intervention 1: RBP-7000 90 mg and 120 mg were a mixture of the ATRIGEL Delivery System and 90 mg and 120 mg risperidone, respectively. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. Subcutaneous RBP-7000 injections on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29. intervention 2: Subcutaneous injection of placebo using the ATRIGEL Delivery System on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29. intervention 3: Oral risperidone 0.25 mg tablets daily for the first two days of the screening period. The two 0.25 mg tablets confirmed whether study participants had any negative reaction to risperidone prior to receiving a long-acting injection of risperidone (RBP-7000).

Protocol documents:
Clinical trial NCT02128074
Conditions: Anemia of Chronic Kidney Disease
Sponsor: Keryx Biopharmaceuticals
Start date: 2014-04-01; Completion date: 2014-11-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).

Detailed description:
Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients.

This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).

Arms: arm 1: KRX-0502 (ferric citrate)
Interventions: intervention 1: KRX-0502
Intervention descriptions: intervention 1: 1g tablets of KRX-0502

Protocol documents:
Clinical trial NCT02140060
Conditions: Glaucoma Ocular Hypertension
Keywords: Glaucoma Ocular Hypertension OAG POAG OHT
Sponsor: Alcon Research
Start date: 2014-06-01; Completion date: 2014-11-01
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP).

Detailed description:
This study was divided into two phases conducted in sequence. Phase I was the Screening/Eligibility Phase, which included a Screening Visit, followed by two Eligibility Visits. Phase II was the randomized, double-masked, 6-week Treatment Phase which included on-therapy visits at Week 2 and Week 6. Travoprost was administered in 1 of 3 concentration levels (A-C), where A=lowest and C=highest.

Arms: arm 1: Dose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 2: Dose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 3: Dose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 4: Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks arm 5: Brinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 6: Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Interventions: intervention 1: Dose Level A / Brinzolamide 1% ophthalmic suspension intervention 2: Dose Level B / Brinzolamide 1% ophthalmic suspension intervention 3: Dose Level C / Brinzolamide 1% ophthalmic suspension intervention 4: Brinzolamide 1% ophthalmic suspension AZOPT® intervention 5: Travoprost 0.004% ophthalmic solution TRAVATAN Z® intervention 6: Travoprost solution vehicle intervention 7: Brinzolamide suspension vehicle
Intervention descriptions: intervention 1: Fixed combination intervention 2: Fixed combination intervention 3: Fixed combination intervention 4: None intervention 5: None intervention 6: Inactive ingredients used for masking purposes intervention 7: Inactive ingredients used for masking purposes

Protocol documents: