ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00633022
Conditions: Atherosclerosis
Keywords: FDG-PET/CT, atherosclerosis
Sponsor: GlaxoSmithKline
Start date: 2008-06-02; Completion date: 2009-12-03
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to assess the potential anti-inflammatory effects of a 3-month treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques, as assessed by FDG-PET/CT.

Detailed description:

Arms: arm 1: Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks arm 2: Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks. arm 3: Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
Interventions: intervention 1: LOSMAPIMOD 7.5 MG intervention 2: Placebo
Intervention descriptions: intervention 1: GW856553 tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised GW856553X active substance. Tablets are available containing 7.5 mg of GW856553X and are packed into high-density polyethylene (HDPE) bottles. intervention 2: Placebo tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised substance to visually match the active GW856553 tablets are also available. Tablets are packed into high-density polyethylene (HDPE) bottles.

Protocol documents:
Clinical trial NCT01332071
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin Rosiglitazone Healthy volunteers Avandamet Fed conditions Bioequivalence
Sponsor: GlaxoSmithKline
Start date: 2009-11-24; Completion date: 2009-12-06
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.

Detailed description:
This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals. Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets. Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith Kline Brasil Ltda) in the form of film coated tablets. The population is composed by 26 healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years. Their body mass index (BMI) varied between 18,5 and 25. There are no restrictions regarding the ethnic group. The relative bioavailability of the two formulations, after oral administration, will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood.

Arms: arm 1: Test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 miligrams (mg) + 1000 mg in Period 1, followed by a 7-day washout period during which no medication was administered, followed by reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 mg + 500 mg in Period 2 arm 2: Reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 miligrams (mg) + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 mg + 1000 mg in Period 2
Interventions: intervention 1: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg intervention 2: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Intervention descriptions: intervention 1: Avandamet reference product intervention 2: Avandamet test product

Protocol documents:
Clinical trial NCT00642304
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-03-27; Completion date: 2009-12-09
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Intervention descriptions: intervention 1: Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.

Protocol documents:
Clinical trial NCT01033643
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-05-27; Completion date: 2009-12-09
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MK-3614 in male participants with mild to moderate hypertension. The primary hypotheses are: 1) Multiple oral doses of MK-3614 are sufficiently safe and well tolerated to permit continued clinical investigation 2) Aortic Augmentation Index (Aix) is reduced 24 hours post the last dose of MK-3614 administered compared to placebo and 3) Increase in the 12-hour weighted averages (TWA 0-12hours) of the heart rate is within 15 beats per minute (bpm) of baseline on first day of multiple dosing of MK-3614 and within 10 bpm of baseline on last day of multiple dosing of MK-3614.

Detailed description:

Arms: arm 1: Participants received 0.25 mg of MK-3614 twice daily (BID) every 12 hours orally for 10 days. arm 2: Participants received 0.50 mg of MK-3614 in the morning (AM) and 0.25 mg of MK-3614 in the evening (PM) 12 hours apart orally for 10 days. arm 3: Participants were to receive 0.75 mg of MK-3614 BID every 12 hours orally for 10 Days. Per protocol amendment, the Panel B dose was repeated, and participants received instead 0.50 mg of MK-3614 in the AM, and 0.25 mg of MK-3614 in the PM, 12 hours apart orally for 10 days. arm 4: Participants received 0.50 mg of MK-3614 three times a day (TID) orally every 8 hours on Day 1 followed by a wash out period for Days 2, 3 and 0.50 mg of MK-3614 every 12 hours orally for 10 days (Days 4-13). arm 5: Participants were to receive orally 0.50 mg of MK-3614 BID every 12 hours on Day 1 followed by 3 doses (0.50/0.50/0.25 mg) of MK-3614 each 8 hours apart on Day 2; three doses of 0.50 mg of MK-3614 8 hours apart on Days 3,4; and 0.75 mg of MK-3614 BID every 12 hours on Days 5-14. No participants were enrolled in this group. arm 6: Participants received a dose matched placebo orally according to randomization.
Interventions: intervention 1: MK-3614 intervention 2: Placebo for MK-3614
Intervention descriptions: intervention 1: Participants were administered 0.25 mg tablet, orally for a total daily dose according to randomization. intervention 2: Participants were administered dose matched placebo tablets according to randomization.

Protocol documents:
Clinical trial NCT04053270
Conditions: Erythropoietic Protoporphyria
Keywords: Erythropoietic Protoporphyria EPP Afamelanotide
Sponsor: Clinuvel Pharmaceuticals Limited
Start date: 2007-05-01; Completion date: 2009-12-09
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythropoietic Protoporphyria (EPP).

The study was conducted with two parallel study arms with crossover between treatments every 60 days.

Eligible patients were randomised to a treatment group, and received implants of active treatment (afamelanotide 16mg) or placebo, in an alternating crossover fashion according to the following dosing regime:

* Group A was administered active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300
* Group B was administered placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300

Detailed description:
Afamelanotide is a man-made drug being studied for use as a preventative medication for Erythropoietic Protoporphyria (EPP) sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH).

The study will involve the use of an implant, which comes in the form of a small rod to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication).

This study aims to provide insight into the effectiveness of afamelanotide under normal conditions of use in EPP patients.

Arms: arm 1: Group A was administered active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300 arm 2: Group B was administered placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300
Interventions: intervention 1: Afamelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: 16mg subcutaneous implant intervention 2: Placebo subcutaneous implant

Protocol documents:
Clinical trial NCT00734578
Conditions: ADHD
Sponsor: Shire
Start date: 2008-09-02; Completion date: 2009-12-10
Enrollment: 461 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

Detailed description:

Arms: arm 1: SPD503 (Guanfacine Extended Release) arm 2: SPD503 (Guanfacine Extended Release) arm 3: None
Interventions: intervention 1: SPD503-AM intervention 2: SPD503-PM intervention 3: Placebo
Intervention descriptions: intervention 1: SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg intervention 2: SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg intervention 3: Placebo matched to Guanfacine Hydrochloride Extended Release

Protocol documents:
Clinical trial NCT00468728
Conditions: Clostridium Infections Diarrhea
Keywords: CDAD, Clostridium difficile, diarrhea Clostridium difficile-Associated Diarrhea
Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2006-10-04; Completion date: 2009-12-11
Enrollment: 535 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Detailed description:
The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Arms: arm 1: Vancomycin arm 2: PAR-101/OPT-80
Interventions: intervention 1: PAR-101/OPT-80 intervention 2: Vancomycin
Intervention descriptions: intervention 1: capsules intervention 2: Capsules

Protocol documents:
Clinical trial NCT00748410
Conditions: Colitis, Ulcerative
Keywords: CD11b Ulcerative colitis 99mTc-HMPAO-labelled leukocyte scintigraphy
Sponsor: GlaxoSmithKline
Start date: 2009-01-22; Completion date: 2009-12-12
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis. 99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe the effect of SB656933 on the migration of PMN to inflamed tissue.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SB-656933
Intervention descriptions: intervention 1: 7 days repeat dose

Protocol documents:
Clinical trial NCT00688597
Conditions: Pompe Disease
Keywords: Amicus Therapeutics Duvoglustat AT2220
Sponsor: Amicus Therapeutics
Start date: 2008-12-08; Completion date: 2009-12-14
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study was to determine the safety and tolerability of 3 different doses of duvoglustat (AT2220) in participants affected by Pompe disease. The study also evaluated the effects of duvoglustat on functional parameters in Pompe disease.

Detailed description:
This was a Phase 2, open-label study in participants with Pompe disease, a lysosomal storage disorder. Duvoglustat is designed to act as a pharmacological chaperone of alpha-glucosidase, in order to restore enzyme activity. This study consisted of a 28-day screening period, an 11-week treatment period, and a 1-week follow-up period. Three dosing regimens of oral duvoglustat were to be evaluated (Cohort 1: 2.5 g daily for 3 days, followed by no study drug for 4 days; Cohort 2: 5 g daily for 3 days, followed by no study drug for 4 days; Cohort 3: 5 g daily for 7 days, followed by no study drug for 7 days).

Participants meeting all eligibility criteria underwent physical examination, electrocardiogram, spirometry, muscular strength test, functional muscle test, 6-minute walk test (when appropriate), laboratory tests, magnetic resonance imaging, and muscle (needle) biopsy. Quality of life was assessed via the 36-Item Short Form Health Survey questionnaire. Functional ability and level of handicap was assessed by Rotterdam handicap scale.

Arms: arm 1: Regimen 1: Low-dose duvoglustat (2.5 grams \[g\]) once a day (QD) for 3 days, followed by no drug for 4 days, for 11 weeks. arm 2: Regimen 1: High-dose duvoglustat (5.0 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks. arm 3: Regimen 2: High-dose duvoglustat (5.0 g) QD for 7 days, followed by no drug for 7 days, for 11 weeks.
Interventions: intervention 1: Duvoglustat
Intervention descriptions: intervention 1: Powder in a bottle for dissolution in water for oral administration

Protocol documents:
Clinical trial NCT00561821
Conditions: Insomnia Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders
Keywords: elderly randomized placebo controlled
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-11-20; Completion date: 2009-12-21
Enrollment: 538 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)

compared to placebo in elderly participants with chronic primary

insomnia. Primary efficacy variable is Wake time After Sleep

Onset (WASO), averaged over all in-treatment time points

and measured by polysomnography (PSG).

Detailed description:
Insomnia is a common complaint or disorder throughout the

world. About one third of the population in the industrial

countries reports difficulty initiating or maintaining sleep,

resulting in a non-refreshing or non-restorative sleep. The

majority of the insomniacs suffer chronically from their

complaints.

The maleic acid salt of Org 4420, code name Org 50081, known as Esmirtazapine, was

selected for development in the treatment of insomnia. The

first clinical trial with Esmirtazapine was a proof-of-concept trial

with a four-way cross-over design. All 3 Esmirtazapine dose

groups showed a statistically significant positive effect on

TST (objective and subjective) and WASO, as compared to

placebo.

The current study is designed to assess the efficacy and safety

of Esmirtazapine in a double-blind, placebo-controlled, parallel,

randomized trial in elderly participants suffering from chronic

primary insomnia.

Arms: arm 1: one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 2: one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 3: one placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 4: one placebo tablet daily for 14 days, followed by one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
Interventions: intervention 1: Esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: one tablet daily intervention 2: one tablet daily

Protocol documents:
Clinical trial NCT00667628
Conditions: Advanced Hepatocellular Carcinoma
Sponsor: Taiho Oncology, Inc.
Start date: 2008-04-24; Completion date: 2009-12-22
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether TAC-101 combined with Transcatheter Arterial Chemoembolization (TACE) is more effective than TACE alone in slowing tumor activity in patients with advanced hepatocellular carcinoma. The study is also looking at the safety of TAC-101 in combination with TACE.

Detailed description:
Advanced metastatic hepatocellular carcinoma (HCC) is not treatable by surgical approaches or locoregional therapies such as hepatic artery hemoembolization or radiofrequency ablation (RFA) which are effective in controlling localized tumors. Transcatheter arterial chemoembolization (TACE) is the most commonly performed procedure in the treatment of unresectable liver tumors for selected patients. The TACE procedure delivers highly concentrated drugs to the tumor itself and arrests blood flow. Most patients will have intrahepatic recurrence of their tumors following TACE. Studies of TAC-101, a synthetic retinoid, indicate that although TAC-101 may not induce tumor regression, it appears to have a stabilizing effect, prolonging survival over what was expected historically. This study is designed as a randomized, double-blind, placebo-controlled, parallel-group, phase 2 study in patients with advanced HCC who have undergone a TACE procedure, which will be conducted at multiple sites in Japan, to determine if administration of TAC-101 will enhance the benefits of the TACE procedure.

Arms: arm 1: Participants were administered with placebo tablets matching to TAC-101 orally, every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) treatment recovery period. Repeated every 21 days cycle up to new lesions were observed or the participant met a treatment discontinuation criterion. arm 2: Participants were administered with TAC-101 tablets, 20 milligram per day (mg/day) orally for every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) recovery period (21-day Cycle). Repeated every 21 days cycle up to new lesions were observed or the participant met a treatment discontinuation criterion.
Interventions: intervention 1: TAC-101 intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received TAC-101 20 mg (2 x 10-mg formulated tablets) administered orally every day with approximately 8 oz. water within 1 hour following a morning meal for 14 days followed by a 7-day recovery period, repeated every 21 days. intervention 2: Participants received placebo (two matching tablets) at same frequency and duration of active treatment.

Protocol documents:
Clinical trial NCT01330303
Conditions: Prostatic Hyperplasia
Keywords: Bioequivalence Healthy volunteers tamsulosin hydrochloride Fed administration
Sponsor: GlaxoSmithKline
Start date: 2009-12-08; Completion date: 2009-12-22
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.

Detailed description:
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.

The treatment's sequence attributed to each volunteer on the study period is determined by a randomization list, which is generated by PROC PLAN from SAS version 9.1.3 system.

The formulations will be administered as a single oral dose followed by blood collections between, at least, 3 to 5 half-lives. The treatment's periods may obey a minimum interval of 7 half lives between them (period for drug's whole elimination by the organism).

Arms: arm 1: Reference drug administration followed by Test drug administration arm 2: Test drug administration followed by Reference drug administration
Interventions: intervention 1: Reference formulation intervention 2: Test formulation
Intervention descriptions: intervention 1: SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim) intervention 2: tamsulosin hydrochloride 0,4 mg (Synthon BV)

Protocol documents: