ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01430442
Conditions: Migraine Acute Treatment of Migraine
Sponsor: Pfizer
Start date: 2011-10-01; Completion date: 2012-05-01
Enrollment: 1026 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.

Detailed description:
Intervention Model: Parallel Versus Comparator + Placebo

Arms: arm 1: Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. arm 2: Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. arm 3: Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. arm 4: Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. arm 5: Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. arm 6: Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. arm 7: Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. arm 8: Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
Interventions: intervention 1: Rimegepant intervention 2: Placebo intervention 3: Sumatriptan
Intervention descriptions: intervention 1: Rimegepant capsules intervention 2: Rimegepant placebo-matching capsules intervention 3: Rimegepant matching sumatriptan and Rimegepant matching placebo capsules

Protocol documents:
Clinical trial NCT01440595
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-11-28; Completion date: 2012-05-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.

Detailed description:

Arms: arm 1: Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks. arm 2: Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks. arm 3: Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks. arm 4: Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.
Interventions: intervention 1: Grazoprevir intervention 2: Placebo to Grazoprevir intervention 3: Peginterferon alfa-2b (Peg-IFN) intervention 4: Ribavirin (RBV)
Intervention descriptions: intervention 1: Grazoprevir 100 mg tablets once daily for 12 weeks. intervention 2: Placebo to Grazoprevir once daily for 12 weeks intervention 3: Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks intervention 4: Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Protocol documents:
Clinical trial NCT01449513
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2011-09-01; Completion date: 2012-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by reflectance confocal microscopy.

Detailed description:

Arms: arm 1: active ingredient of PEP005: Ingenol mebutate arm 2: Vehicle of PEP005 Gel
Interventions: intervention 1: Ingenol mebutate intervention 2: Placebo Gel
Intervention descriptions: intervention 1: 0.05% Ingenol mebutate Gel once daily for 2 consecutive days intervention 2: Gel vehicle of PEP005

Protocol documents:
Clinical trial NCT01461655
Conditions: Acne Vulgaris
Sponsor: LEO Pharma
Start date: 2011-11-01; Completion date: 2012-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: marketed topical retinoid intervention 2: marketed topical NSAID intervention 3: vehicle gel intervention 4: marketed topical retinoid
Intervention descriptions: intervention 1: once daily application, 4 weeks intervention 2: once daily application, 4 weeks intervention 3: once daily application, 4 weeks intervention 4: once daily application, 4 weeks

Protocol documents:
Clinical trial NCT01462929
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD antimuscarinic
Sponsor: AstraZeneca
Start date: 2011-11-01; Completion date: 2012-05-01
Enrollment: 414 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.

Detailed description:

Arms: arm 1: Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment arm 2: Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment arm 3: Placebo comparator administered during 6 weeks of treatment
Interventions: intervention 1: Aclidinium bromide intervention 2: Tiotropium intervention 3: Placebo
Intervention descriptions: intervention 1: Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) intervention 2: Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) intervention 3: Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).

Protocol documents:
Clinical trial NCT01464879
Conditions: Hypogonadal Males
Sponsor: Ferring Pharmaceuticals
Start date: 2011-12-01; Completion date: 2012-05-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application

Detailed description:

Arms: arm 1: Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. arm 2: Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days. arm 3: Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. arm 4: Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days.
Interventions: intervention 1: Testosterone Gel (FE 999303)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01469065
Conditions: Diabetes Mellitus, Type 2
Keywords: inpatient diabetes phase 1
Sponsor: Pfizer
Start date: 2011-12-01; Completion date: 2012-05-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.

Detailed description:

Arms: arm 1: PF-04991532 experimental study medication arm 2: PF-04991532 Matching Placebo
Interventions: intervention 1: PF-04991532 intervention 2: PF-04991532 intervention 3: PF-04991532 intervention 4: PF-0499132 intervention 5: Placebo
Intervention descriptions: intervention 1: Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days intervention 2: Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days intervention 3: Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days intervention 4: Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days intervention 5: Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days

Protocol documents:
Clinical trial NCT01469585
Conditions: Breakthrough Bleeding
Keywords: continuous oral contraceptives Matrix Metalloproteinase expression
Sponsor: University of Hawaii
Start date: 2011-11-01; Completion date: 2012-05-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose doxycycline on the irregular bleeding women experience when taking continuous oral contraceptive pills. This research is being done because currently, there is no effective treatment for this condition. Findings from this study could help to decrease the side effects of birth control pills and decrease unplanned pregnancies.

Detailed description:
Continuous oral contraceptive administration entails women taking hormonally active pills for 28 days without a seven day placebo week to avoid hormonal withdrawal bleeding. Unfortunately, with continuous administration, timed, regular bleeding can be replace by irregular, unscheduled bleeding, which often leads to dissatisfaction, discontinuation and the possibility of unplanned pregnancy.

Matrix Metalloproteinases, a group of zinc-dependant proteases, are hypothesized to play a role in endometrial degradation. The purpose of this study is to describe the expression of Matrix Metalloproteinases in endometrial biopsy specimens collected 1) prior to initiating oral contraceptives 2) while taking cyclic oral contraceptive 3) while taking continuous oral contraceptives and 4) while taking continuous oral contraceptives along with sub-antimicrobial doxycycline.

Arms: arm 1: Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill. arm 2: Women will take only the continuous oral contraceptive.
Interventions: intervention 1: Doxycycline
Intervention descriptions: intervention 1: 40 mg orally at the start of cycle 3 (study day 57) for 28 days.

Protocol documents:
Clinical trial NCT01484197
Conditions: Asthma
Keywords: Asthma Indacaterol QAB149
Sponsor: Novartis Pharmaceuticals
Start date: 2011-11-01; Completion date: 2012-05-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.

Detailed description:

Arms: arm 1: 75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. arm 2: 75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. arm 3: 37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. arm 4: Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Interventions: intervention 1: 75 µg indacaterol maleate (LB) intervention 2: 75 µg indacaterol maleate (PoS) intervention 3: 37.5 µg indacaterol maleate (PoS) intervention 4: placebo to indacaterol (LB) intervention 5: placebo to indacaterol (PoS)
Intervention descriptions: intervention 1: 75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. intervention 2: 75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. intervention 3: 37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. intervention 4: Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. intervention 5: Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Protocol documents:
Clinical trial NCT01485770
Conditions: Narcolepsy
Sponsor: Jazz Pharmaceuticals
Start date: 2011-12-01; Completion date: 2012-05-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.

Detailed description:

Arms: arm 1: Participants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They will then receive ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4). arm 2: Participants first receive ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
Interventions: intervention 1: ADX-N05 intervention 2: Placebo
Intervention descriptions: intervention 1: 150 mg once a day for seven days followed by 300 mg once a day for seven days intervention 2: Placebo to match ADX-N05 once a day for 2 consecutive weeks

Protocol documents:
Clinical trial NCT01486446
Conditions: Primary Erythromelalgia Inherited Erythromelalgia
Keywords: IEM EM Erythromelalgia Erythermalgia Red neuralgia Peripheral Vascular Disease Vascular Disease Cardiovascular Disease
Sponsor: Xenon Pharmaceuticals Inc.
Start date: 2011-12-01; Completion date: 2012-05-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.

Detailed description:
Your role in the study would include:

* Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each lasting approximately 1 day
* Travelling and staying in the clinic for 2 in-patient stays:
* For the first in-patient visit you will have to spend 8 days and 7 nights in the clinic
* For the second in-patient visit you will have to spend 2 days and 1 night in the clinic You can bring books, laptops and DVDs to the clinic.

If you do not live within driving distance to the clinic you will need to stay in the local area (in Anniston, at a local hotel) for 1 to 2 weeks while you use the ointment, in addition to the in-patient portion of the study.

Arms: arm 1: XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days arm 2: XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
Interventions: intervention 1: XPF-002 intervention 2: Placebo
Intervention descriptions: intervention 1: XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days intervention 2: XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.

Protocol documents:
Clinical trial NCT01500772
Conditions: Hepatitis C
Keywords: Hepatitis C PI treatment failure
Sponsor: Debiopharm International SA
Start date: 2012-03-01; Completion date: 2012-05-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

Detailed description:

Arms: arm 1: ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Interventions: intervention 1: Alisporivir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: ALV 200 mg soft gel capsules administered orally intervention 2: PEG 180 μg administered via subcutaneous (s.c.) injection once weekly intervention 3: RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Protocol documents:
Clinical trial NCT01508455
Conditions: Anesthesia
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Start date: 2012-03-01; Completion date: 2012-05-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through \< 36 weeks gestational age.

Detailed description:

Arms: arm 1: Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Interventions: intervention 1: Dexmedetomidine intervention 2: Midazolam intervention 3: Fentanyl intervention 4: Morphine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01512160
Conditions: Post-surgical Dental Pain
Keywords: Post-surgical dental pain
Sponsor: Pfizer
Start date: 2011-10-01; Completion date: 2012-05-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF-04531083 intervention 2: Placebo intervention 3: PF-04531083 intervention 4: Placebo intervention 5: Ibuprofen intervention 6: Placebo intervention 7: Placebo intervention 8: Placebo
Intervention descriptions: intervention 1: 2000 mg oral solution intervention 2: Placebo tablets for Ibuprofen intervention 3: 1000 mg oral solution intervention 4: Placebo tablets for Ibuprofen intervention 5: 2 x 200 mg tablets intervention 6: Placebo solution for PF-04531083 intervention 7: Placebo solution for PF-04531083 intervention 8: Placebo tablets for Ibuprofen

Protocol documents:
Clinical trial NCT01518699
Conditions: Pediculosis
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2012-01-01; Completion date: 2012-05-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.

Detailed description:
This study was a randomized, double-blind, placebo- and active-controlled, crossover study that evaluated the potential of Abametapir to prolong cardiac repolarization in healthy adult subjects (total of 57 subjects).

Arms: arm 1: Study drug plus positive-control placebo. arm 2: Placebo plus positive-control placebo. arm 3: Placebo plus positive control
Interventions: intervention 1: Ha44 intervention 2: Ha44 Placebo intervention 3: Moxifloxacin Placebo intervention 4: Moxifloxacin
Intervention descriptions: intervention 1: Abametapir Lotion 0.74% intervention 2: Ha44 Vehicle Gel without Abametapir intervention 3: Moxifloxacin Placebo intervention 4: Moxifloxacin 400mg

Protocol documents: