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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: | NCT00240773 |
Purpose
The purpose of this study is to compare the long-term safety and effectiveness of acetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment of osteoarthritis of the hip or knee.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Hip Osteoarthritis, Knee |
Drug: acetaminophen Drug: naproxen |
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, Long-Term Comparative Study Evaluating the Safety and Efficacy of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee |
| Enrollment: | 581 |
| Study Completion Date: | June 2003 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
acetaminophen 4 grams daily for 12 months
|
Drug: acetaminophen
4 grams daily for 12 months
|
|
Active Comparator: 002
naproxen 750 mg daily for 12 months
|
Drug: naproxen
750 mg daily for 12 months
|
|
Experimental: 003
acetaminophen 4 grams daily for six months
|
Drug: acetaminophen
4 grams daily for six months
|
|
Active Comparator: 004
naproxen 750 mg daily for six months
|
Drug: naproxen
750 mg daily for six months
|
This is a randomized, double-blind study to compare the long term safety profile and effectiveness of acetaminophen, given at a dose of 1000 mg every four to six hours, and naproxen, given at a dose of 375 mg twice daily (with matching placebo given four times daily to maintain the blind), in the treatment of osteoarthritis of the hip or knee. There are two groups of subjects. Group 1 has approximately 480 subjects randomized and a treatment duration of 12 months. Group 2 has approximately 80 subjects randomized and a treatment duration of 6 months. The primary measure of efficacy is the change from baseline in the WOMAC Osteoarthritis Index pain subscale at month 6. Safety evaluations, throughout the course of the study, include monitoring adverse events, laboratory tests and assessments of vital signs including respiration rate, pulse, blood pressure, and body weight. Subjects are instructed to take a dose of medication orally, every 4-6 hours. The acetaminophen subjects take a total daily dose of 4 g of acetaminophen. The naproxen subjects a total daily dose of 750 mg of naproxen. The treatment duration is 12 and 6 months in Group 1 and Group 2, respectively.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| 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: | NCT00240773 History of Changes |
| Other Study ID Numbers: | CR002197 |
| Study First Received: | October 14, 2005 |
| Last Updated: | June 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
osteoarthritis hip osteoarthritis knee acetaminophen, naproxen |
|
Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Naproxen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |