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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00240799 |
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 |
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Osteoarthritis |
Drug: acetaminophen extended release |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 520 |
Estimated Study Completion Date: | October 2004 |
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 priamry 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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR002488 |
Study First Received: | October 14, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00240799 History of Changes |
Health Authority: | United States: Food and Drug Administration |
osteoarthritis knee acetaminophen osteoarthritis hip |
Osteoarthritis, Knee Musculoskeletal Diseases Analgesics, Non-Narcotic Osteoarthritis Joint Diseases Arthritis |
Peripheral Nervous System Agents Analgesics Rheumatic Diseases Osteoarthritis, Hip Acetaminophen |
Osteoarthritis Joint Diseases Physiological Effects of Drugs Osteoarthritis, Hip Rheumatic Diseases Pharmacologic Actions Musculoskeletal Diseases Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Arthritis Analgesics Peripheral Nervous System Agents Central Nervous System Agents Acetaminophen |