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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00344045 |
The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.
Condition | Intervention | Phase |
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Pain |
Drug: Paracetamol Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty |
Enrollment: | 86 |
Study Start Date: | April 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: Paracetamol
IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
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B: Placebo Comparator |
Drug: Placebo
IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Local Institution | |
Madrid, Spain, 28041 | |
Local Institution | |
Madrid, Spain, 28007 | |
Local Institution | |
Vizcaya, Spain, 48903 | |
Local Institution | |
Barcelona, Spain, 08024 | |
Local Institution | |
Alcorcon, Spain, 28922 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CN145-010 |
Study First Received: | June 23, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00344045 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Subjects with postoperative pain after Total Hip Arthroplasty |
Signs and Symptoms Postoperative Complications Analgesics, Non-Narcotic Pain |
Peripheral Nervous System Agents Analgesics Acetaminophen Pain, Postoperative |
Physiological Effects of Drugs Pain Pharmacologic Actions Signs and Symptoms Pathologic Processes Postoperative Complications Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Pain, Postoperative Acetaminophen |