ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01189032
Conditions: Dry Eye
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: ; Completion date: 2006-07-01
Enrollment: 320 participants; Allocation: ; Intervention model: 

Brief summary:
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: DE-089 ophthalmic solution intervention 2: DE-089 ophthalmic solution intervention 3: Placebo ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02281591
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2006-06-01; Completion date: 2006-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single centre, open-label, randomised study in four parallel groups of healthy volunteers

Detailed description:
Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

Arms: arm 1: 900mg of eslicarbazepine acetate (ESL, BIA 2-093) arm 2: 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine arm 3: 450 mg of S-licarbazepine arm 4: 450 mg of Rlicarbazepine
Interventions: intervention 1: BIA 2-093 intervention 2: S-licarbazepine intervention 3: R-licarbazepine
Intervention descriptions: intervention 1: Tablets containing 900 mg intervention 2: capsules containing 225 mg intervention 3: capsules containing 225 mg

Protocol documents:
Clinical trial NCT00289198
Conditions: Rhinitis, Allergic, Perennial
Keywords: GW685698X perennial allergic rhinitis allergic rhinitis
Sponsor: GlaxoSmithKline
Start date: 2006-02-07; Completion date: 2006-07-04
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)

Arms: arm 1: Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg arm 2: Participants were instructed to administer two sprays into each nostril once daily every morning of placebo
Interventions: intervention 1: FF intervention 2: Placebo
Intervention descriptions: intervention 1: fluticasone furoate 110 μg nasal spray intervention 2: placebo nasal spray

Protocol documents:
Clinical trial NCT00097695
Conditions: Angioedema
Keywords: Hereditary Angioedema C1 inhibitor deficiency HAE Icatibant Bradykinin antagonist acute attack subcutaneous
Sponsor: Shire
Start date: 2004-12-28; Completion date: 2006-07-17
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).

Detailed description:
This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treated cutaneous and/or abdominal attack in randomised patients. Patients experienced a laryngeal attack were not randomised, but treated with open label icatibant according to the controlled phase procedures and assessments. The outcome of this group was to be reported descriptively. After treatment of the first attack in the controlled phase, the patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the end of the study.The OLE phase became a modified open label extension where all 56 patients who had been randomised and the last randomised patient had concluded the double-blind phase. The modified open label extension period permitted treatment for patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the double blind phase was still ongoing.

Arms: arm 1: Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack. arm 2: Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack. arm 3: Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. arm 4: Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing (they were not treated during the Controlled phase but treated with icatibant during the Open Label Extension Phase (OLE) )
Interventions: intervention 1: Icatibant intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg (3mL) subcutaneous icatibant injection in the abdominal region intervention 2: Solution for injection, matched to study drug Single dose: 3 mL

Protocol documents:
Clinical trial NCT00320398
Conditions: Thrombosis, Venous
Keywords: Fondaparinux Hip Replacement Arthroplasty VTE THR MOSLL pentasaccharide Xa factor
Sponsor: GlaxoSmithKline
Start date: 2006-01-30; Completion date: 2006-07-18
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).

Detailed description:

Interventions: intervention 1: Fondaparinux
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00500656
Conditions: Hereditary Angioedema
Sponsor: Shire
Start date: 2005-03-01; Completion date: 2006-07-25
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Outcome Measures:

The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid.

Secondary Outcome Measures:

* Additional efficacy assessments (Time to Almost Complete Symptom Relief)
* Safety and tolerability
* Pharmacoeconomics

Detailed description:
This was a Phase III, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of HAE.

The study consisted of two parts: controlled phase and OLE phase. For the primary endpoint, Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid.

Arms: arm 1: Subjects received S.C icatibant+ oral placebo

Icatibant Form: solution for injection, 3 mL, 10 mg/mL Single dose: 30 mg (3 mL)

Placebo Form: hard capsule Single dose: 2 capsules Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart arm 2: Subjects received oral Tranexamic acid+ S.C. placebo

Tranexamic acid Form: over encapsulated film tablet Single dose: 1000 mg (2 capsules) Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart

Placebo Form: solution for injection, matched to icatibant for injection Single dose: 3 mL Frequency: one subcutaneous injection in the abdominal region arm 3: Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. arm 4: Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
Interventions: intervention 1: Icatibant intervention 2: Tranexamic Acid intervention 3: Oral Placebo intervention 4: S.C. Placebo
Intervention descriptions: intervention 1: Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist. intervention 2: over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE. intervention 3: hard capsule matched to tranexamic acid intervention 4: solution for injection, matched to icatibant for injection

Protocol documents:
Clinical trial NCT00158860
Conditions: Herpes Genitalis
Keywords: VALTREX® valaciclovir genital herpes HSV-2 suppression
Sponsor: GlaxoSmithKline
Start date: 2004-06-21; Completion date: 2006-07-26
Enrollment: 384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.

Detailed description:

Arms: arm 1: Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). arm 2: Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).
Interventions: intervention 1: Valaciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: 1g once daily intervention 2: placebo

Protocol documents:
Clinical trial NCT00102063
Conditions: Schizophrenia
Keywords: Schizophrenia Aripiprazole
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2004-07-01; Completion date: 2006-08-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Detailed description:

Arms: arm 1: Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 arm 2: Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 arm 3: Participants were given a single pill administered once daily
Interventions: intervention 1: Aripiprazole tablet, 10 mg intervention 2: Aripiprazole tablet, 30 mg intervention 3: Placebo tablet
Intervention descriptions: intervention 1: Aripiprazole tablet 10 mg po qd x 42 days intervention 2: Aripiprazole tablet 30 mg po qd x 42 days intervention 3: Placebo tablet po qd x 42 days

Protocol documents:
Clinical trial NCT00047697
Conditions: Autistic Disorder
Sponsor: University of Pittsburgh
Start date: 2002-10-01; Completion date: 2006-08-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 11-week study will examine the safety and effectiveness of the medication donepezil (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents with Autism Spectrum Disorder.

Detailed description:
Children with autism spectrum disorder (ASD) often have impaired communication, problems with social interaction, and repetitive and stereotyped patterns of behavior. While most research has attempted to treat the behavioral deficits commonly associated with ASD, few studies have attempted to improve the core features of this disorder. A recent study found that donepezil HCl helped to improve speech production, attention span, and ability to express emotions in a group of children with autism. This study will provide an opportunity to conduct further testing of the effects of donepezil HCl on the cognitive deficits presumed to underlie the core features of ASD.

This study begins at Week 1 with a baseline assessment. Participants are then randomly assigned to either donepezil HCl or placebo. Participants will start with either a 5mg/day dose of donepezil HCl or placebo followed by a cognitive assessment after 4 weeks on this dose. Participants will then have their dose increased to 10mg/day. Another cognitive assessment will be given after 4 weeks on this dose.

Arms: arm 1: Donepezil HCL 5 mg and 10 mg arm 2: Placebo
Interventions: intervention 1: Donepezil HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks. intervention 2: Placebo used in placed of Donepezil HCL

Protocol documents:
Clinical trial NCT00062647
Conditions: Gram-Positive Bacterial Infections
Sponsor: Cumberland Pharmaceuticals
Start date: 2003-08-01; Completion date: 2006-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.

Detailed description:

Arms: arm 1: None arm 2: Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
Interventions: intervention 1: Telavancin intervention 2: Vancomycin, nafcillin, oxacillin, or cloxacillin
Intervention descriptions: intervention 1: Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days intervention 2: Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.

Protocol documents:
Clinical trial NCT00069108
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2003-07-01; Completion date: 2006-08-01
Enrollment: 627 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m\^2 intravenous (IV) infusion over 2 hours (every 3 weeks \[Day 1\]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks). arm 2: Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin \[LV\] and 5-fluorouracil \[5-FU\] combination). Oxaliplatin was administered as an 85 mg/m\^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m\^2 over 2 hours followed by 5-FU, given as 400mg/m\^2 bolus injection over 2-4 minutes, and then as a 600 mg/m\^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m\^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Interventions: intervention 1: 5 FU intervention 2: Leucovorin intervention 3: Oxaliplatin intervention 4: Oxaliplatin intervention 5: capecitabine [Xeloda]
Intervention descriptions: intervention 1: As prescribed, in 2 week cycles intervention 2: As prescribed, in 2 week cycles intervention 3: As prescribed, in 3 week cycles intervention 4: As prescribed, in 2 week cycles intervention 5: 1000mg/m2 po bid on days 1-15 of each 3 week cycle

Protocol documents:
Clinical trial NCT00090584
Conditions: Urinary Incontinence (UI)
Keywords: Urge urinary incontinence (UUI) Drug/Behavior treatment
Sponsor: Carelon Research
Start date: 2004-08-01; Completion date: 2006-08-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.

Detailed description:

Arms: arm 1: Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training. arm 2: Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
Interventions: intervention 1: Tolterodine intervention 2: Behavioral training
Intervention descriptions: intervention 1: 4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects. intervention 2: Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.

Protocol documents:
Clinical trial NCT00144963
Conditions: Acute Lymphoblastic Leukemia
Sponsor: Acrotech Biopharma Inc.
Start date: 2002-07-01; Completion date: 2006-08-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Detailed description:
OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
* Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

Arms: arm 1: Vincristine Sulfate Liposomes Injection (VSLI)
Interventions: intervention 1: Vincristine Sulfate Liposomes Injection intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days). intervention 2: Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).

Protocol documents:
Clinical trial NCT00156819
Conditions: Asthma
Keywords: Asthma Asthma Control
Sponsor: JHSPH Center for Clinical Trials
Start date: 2003-06-01; Completion date: 2006-08-01
Enrollment: 500 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

Detailed description:
This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).

Arms: arm 1: Participants continued fluticasone (100 microgram twice daily) treatment. arm 2: Participants were changed to Montelukast (5 or 10 mg each night). arm 3: Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
Interventions: intervention 1: fluticasone intervention 2: montelukast intervention 3: Fluticasone plus salmeterol
Intervention descriptions: intervention 1: fluticasone (100 microgram twice daily) treatment intervention 2: Montelukast (5 or 10 mg each night). intervention 3: fluticasone (100 microgram) plus salmeterol (50 microgram) each night

Protocol documents: