ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00508404
Conditions: Metastatic Colorectal Cancer
Sponsor: Amgen
Start date: 2007-05-09; Completion date: 2012-06-12
Enrollment: 154 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).

Detailed description:

Arms: arm 1: Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
Interventions: intervention 1: Panitumumab intervention 2: FOLFIRI
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m², leucovorin 400 mg/m², 5-fluorouracil bolus 400 mg/m², 5-fluorouracil infusion 2400 mg/m².

Protocol documents:
Clinical trial NCT03072719
Conditions: Dentine Hypersensitivity
Sponsor: GlaxoSmithKline
Start date: 2012-03-01; Completion date: 2012-06-12
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.

Detailed description:

Arms: arm 1: Toothpaste arm 2: Toothpaste
Interventions: intervention 1: Stannous Fluoride intervention 2: Sodium Monofluorophosphate
Intervention descriptions: intervention 1: Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. intervention 2: Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.

Protocol documents:
Clinical trial NCT01148810
Conditions: Polymyositis Dermatomyositis
Keywords: Inflammatory muscle disease, Muscle weakness, Myositis, inflammatory myopathy, inclusion body myositis, skin rash, autoimmune, difficulty swallowing, dysphagia
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-15; Completion date: 2012-06-13
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects received BAF312 treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BAF312 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01240694
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus SLE
Sponsor: Cephalon, Inc.
Start date: 2010-12-09; Completion date: 2012-06-14
Enrollment: 136 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).

Detailed description:

Arms: arm 1: Participants will receive 200 micrograms (mcg) of CEP-33457
Interventions: intervention 1: CEP-33457
Intervention descriptions: intervention 1: CEP-33457 will be administered subcutaneously per dose specified in the arm description.

Protocol documents:
Clinical trial NCT01465412
Conditions: Chronic Hepatic Impairment
Keywords: Parkinson disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-11-10; Completion date: 2012-06-14
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. Part 2 compares healthy volunteers with participants with moderate hepatic impairment. Healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval \[0.50, 2.00\].

Detailed description:

Arms: arm 1: Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1. arm 2: Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1. arm 3: Participants with moderate chronic liver disease enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1. arm 4: Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
Interventions: intervention 1: Preladenant
Intervention descriptions: intervention 1: After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.

Protocol documents:
Clinical trial NCT01451385
Conditions: Osteoarthritis Low Back Pain
Sponsor: Mallinckrodt
Start date: 2011-09-20; Completion date: 2012-06-18
Enrollment: 376 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs).

Detailed description:

Arms: arm 1: Participants receive 2 tablets of COV795 every 12 hours for up to 35 days
Interventions: intervention 1: COV795
Intervention descriptions: intervention 1: COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)

Protocol documents:
Clinical trial NCT01223378
Conditions: Intraocular Pressure
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-12-13; Completion date: 2012-06-22
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.

Detailed description:

Arms: arm 1: ophthalmic solution arm 2: ophthalmic solution
Interventions: intervention 1: BOL-303259-X intervention 2: Latanoprost
Intervention descriptions: intervention 1: ophthalmic solution, various concentrations, once daily (QD) 28 days intervention 2: 0.005% ophthalmic solution, QD 28 days

Protocol documents:
Clinical trial NCT02454075
Conditions: Zollinger-Ellison Syndrome
Keywords: YF476 netazepide gastric carcinoids Zollinger-Ellison syndrome
Sponsor: Trio Medicines Ltd.
Start date: 2011-04-11; Completion date: 2012-06-22
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate whether treatment with YF476 is safe and effective in reducing the size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL cells, in patients with Zollinger-Ellison syndrome.

Detailed description:

Arms: arm 1: The dose will be 100 mg YF476 once daily. When 6 patients have completed 12 weeks' treatment with that dose, it may be increased to 150 or 200 mg once daily. Patients will have type II gastric carcinoids and/or ECL cell hyperplasia/dysplasia.
Interventions: intervention 1: YF476
Intervention descriptions: intervention 1: Gastrin receptor antagonist

Protocol documents:
Clinical trial NCT01529346
Conditions: Postoperative Dental Pain
Keywords: Postoperative dental pain
Sponsor: Pfizer
Start date: 2011-12-12; Completion date: 2012-06-25
Enrollment: 235 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: PF-05089771 intervention 2: Placebo intervention 3: PF-05089771 intervention 4: Placebo intervention 5: PF-05089771 intervention 6: Placebo intervention 7: Ibuprofen intervention 8: Placebo intervention 9: Placebo intervention 10: Placebo
Intervention descriptions: intervention 1: A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively intervention 2: Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively intervention 3: A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively intervention 4: Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively intervention 5: A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively intervention 6: Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively intervention 7: 2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively intervention 8: Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively intervention 9: Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively intervention 10: Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Protocol documents:
Clinical trial NCT00855465
Conditions: Pulmonary Hypertension
Keywords: Chronic thromboembolic pulmonary hypertension PH soluble Guanylate Cyclase Stimulator sGC
Sponsor: Bayer
Start date: 2009-02-23; Completion date: 2012-06-27
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Detailed description:
Adverse event data will be covered in Adverse events section.

Arms: arm 1: Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks arm 2: Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Placebo
Intervention descriptions: intervention 1: BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks. intervention 2: Matching Placebo tid orally for 16 weeks

Protocol documents:
Clinical trial NCT01340027
Conditions: Urologic Diseases Urinary Bladder Diseases Urological Manifestations Signs and Symptoms Urinary Bladder, Overactive
Keywords: Urinary incontinence Overactive bladder (OAB) Micturition Frequency YM178 Urgency incontinence Urgency
Sponsor: Astellas Pharma Europe B.V.
Start date: 2011-03-29; Completion date: 2012-06-28
Enrollment: 1307 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

Detailed description:

Arms: arm 1: Participants received matching placebo tablets orally once a day for 12 weeks arm 2: Participants received mirabegron 25 mg tablets orally once a day for 12 weeks arm 3: Participants received mirabegron 50 mg tablets orally once a day for 12 weeks arm 4: Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks arm 5: Participants received solifenacin 5 mg tablets orally once a day for 12 weeks arm 6: Participants received solifenacin 10 mg tablets orally once a day for 12 weeks arm 7: Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks arm 8: Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks arm 9: Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks arm 10: Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks arm 11: Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks arm 12: Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Interventions: intervention 1: Mirabegron intervention 2: Solifenacin succinate intervention 3: Placebo
Intervention descriptions: intervention 1: oral intervention 2: oral intervention 3: oral

Protocol documents:
Clinical trial NCT01135459
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Sponsor: Cephalon, Inc.
Start date: 2010-06-24; Completion date: 2012-06-30
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of a 200 micrograms (mcg) dose of CEP-33457 compared with placebo in participants with active systemic lupus erythematosus (SLE) as assessed by the proportion of participants achieving a combined clinical response using the SLE responder index (SRI) at Week 24.

Detailed description:
The study consisted of a 2-week screening period (visit 1), a 20-week treatment period beginning with a baseline visit in which randomization was completed and study drug treatment began (visits 2 through 7), and a final assessment was performed 4 weeks after the last dose of study drug (visit 8 \[week 24 or early termination\]). Participants were randomized to receive either CEP-33457 or placebo subcutaneously (SC) every 4 weeks. Plasma samples for measurement of study drug concentration were collected in a subset of participants and study drug was administered at each study visit until the final visit. The dose of background steroid medication may have been increased, if needed, to treat the participant for minor fluctuations in lupus disease activity. One interim analysis was conducted when at least 80 participants completed Week 12 or had been withdrawn from the study. Participants who completed the treatment period returned to the study center 4 weeks after the last dose had been administered for final procedures and assessments. Final procedures and assessments for participants who withdrew from the study before 20 weeks of treatment were performed at the last visit. Final procedures and assessments for participants who participated in the study beyond week 24 were to be performed at the next regularly scheduled visit. Participants who complete the study will be eligible for participation in the 12-month open-label study (study C33457/3075; herein referred to as study 3075) to assess continued effectiveness and safety of the CEP-33457 treatment.

Arms: arm 1: Participants will receive CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20). arm 2: Participants will receive placebo matching to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
Interventions: intervention 1: CEP-33457 intervention 2: Placebo
Intervention descriptions: intervention 1: CEP-33457 will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to CEP-33457 will be administered per schedule specified in the arm description.

Protocol documents:
Clinical trial NCT01493024
Conditions: Hyperkalemia Chronic Kidney Disease Kidney Dysfunction
Sponsor: ZS Pharma, Inc.
Start date: 2011-11-30; Completion date: 2012-06-30
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is hypothesized that zirconium silicate is safe and well tolerated and more effective than placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum potassium between 5 - 6.0 mmol/l versus no difference between zirconium silicate and placebo (null hypothesis). It is hypothesized that zirconium silicate even up to the top dose of 10g three times a day is well tolerated.

Detailed description:
A total of 90 subjects with moderate CKD (defined as GFR between 40- 60ml/min) and mild hyperkalemia (S-K between 5-6 mmol/l) will be enrolled in the study where, in a double-blind dose-escalating fashion (three separate cohorts), they will be randomized to receive one of the doses of ZS (0.3g, 3g and 10g) or placebo, administered 3 times (tid) daily with meals. The first cohort will have 18 subjects while both of the second and third cohorts will have 36 subjects for a total of 90 subjects.

Safety and tolerability will be assessed by an Independent Data Safety Monitoring Board (DSMB) after completion of each cohort, before escalation to the next dose level will be allowed. The next dose escalation will happen no sooner than one week after the last dose of study drug at the previous dosing level has been administered. Safety stopping rules will be specified for this study. Within the first dose level (300 mg dose), 12 subjects will be randomized to receive ZS, whereas 6 subjects will be randomized to receive placebo for a total of 18 subjects in this first cohort. In the next two cohorts (3 g and 10 g doses), 24 subjects per cohort will be randomized to receive ZS, whereas 12 subjects per cohort will be randomized to receive placebo for a total of 36 subjects in each of the second and third cohorts.

Arms: arm 1: Placebo (silicified microcrystalline cellulose) randomized to mimic escalating doses of experimental drug administered three times daily (TID) with meals. arm 2: Randomized escalating doses (0.3g, 3g and 10g) of ZS (fractionated, protonated, microporous zirconium silicate, an oral sorbent) administered 3 times daily (tid) with meals.
Interventions: intervention 1: Zirconium silicate (ZS) intervention 2: Placebo
Intervention descriptions: intervention 1: Randomized escalating doses (0.3g, 3g and 10g) of ZS (fractionated, protonated microporous Zirconium Silicate, an oral sorbent) administered 3 times daily (tid) with meals. intervention 2: Randomized to mimic escalating doses of experimental drug administered 3 times daily (tid) with meals.

Protocol documents:
Clinical trial NCT00254293
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2006-01-01; Completion date: 2012-07-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: Long Term
Interventions: intervention 1: Abatacept or Placebo (both as IV & SC Solution) intervention 2: Abatacept or Placebo (both as IV & SC Solution) intervention 3: Abatacept or Placebo (both as IV & SC solution) intervention 4: Abatacept or Placebo (both as IV & SC solution) intervention 5: Abatacept or Placebo (both as IV & SC solution) intervention 6: Abatacept
Intervention descriptions: intervention 1: Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE). intervention 2: Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE). intervention 3: Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE). intervention 4: Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE). intervention 5: Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE). intervention 6: Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly

Protocol documents:
Clinical trial NCT01271933
Conditions: Fibromyalgia
Keywords: fibromyalgia pain pregabalin Lyrica
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 441 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: controlled release tablet; 165-495 mg/day; given once daily intervention 2: matching placebo tablet; given once daily

Protocol documents: