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| Sponsor: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
|---|---|
| Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
| ClinicalTrials.gov Identifier: | NCT00240799 |
Purpose
The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: acetaminophen extended release Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee. |
| Enrollment: | 542 |
| Study Completion Date: | October 2004 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
acetaminophen extended release
|
Drug: acetaminophen extended release |
|
Placebo Comparator: 002
placebo
|
Drug: placebo |
This is a randomized, double-blind, placebo controlled study to evaluate acetaminophen extended release 3900 mg/day compared with placebo in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks. The hypothesis is that 3900 mg/day acetaminophen extended release is superior to placebo in the relief of signs and symptoms of osteoarthritis of the hip or knee with respect to the three primary effectiveness endpoints. Propoxyphene Hydrochloride Capsules, 65 mg, are used as rescue medication if subjects experience inadequate pain relief. The primary efficacy assessments are the average change from baseline through Week 12 for the WOMAC pain subscale score and the WOMAC physical function subscale score, and the subject's average global assessment of their response to therapy through Week 12. Safety assessments at study visits consist of monitoring adverse events, vital signs, study joint assessments and clinical laboratory determinations. Treatment consists of two acetaminophen 650 mg extended release caplets or two placebo caplets, administered orally every 8 hours for 12 weeks.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
More Information
| ClinicalTrials.gov Identifier: | NCT00240799 History of Changes |
| Other Study ID Numbers: | CR002488 |
| Study First Received: | October 14, 2005 |
| Last Updated: | June 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
osteoarthritis hip osteoarthritis knee acetaminophen |
|
Osteoarthritis Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Antipyretics |
Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |