Osteoarthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (1950 mg/Day or 3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee
The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks.
Status | Completed |
Enrollment | 483 |
Est. completion date | March 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Symptomats of osteoarthritis of the hip or knee for a minimum of six months - History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs, acetaminophen, or another analgesic agent on a regular basis (>= three days per week) for at least three months before the screening visit - History of positive therapeutic benefit with acetaminophen use for osteoarthritis pain - History of osteoarthritis pain (moderate, moderately severe, or severe) of the hip or knee when not taking osteoarthritis analgesic medication - Must have a pain level of moderate or moderately severe for 24 hours over the previous 24 hours prior to the baseline visit, and at baseline, demonstrate a 20% or greater increase in the pain subscale score, relative to the score at screening Exclusion Criteria: - History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit - Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence radiographic criteria - Maximum osteoarthritis pain intensity of none, mild or severe experienced over the previous 24 hours of the baseline visit - Signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Consumer and Personal Products Worldwide |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average change from baseline to the final on-therapy visit for - WOMAC pain subscale score; WOMAC physical function subscale score; and subject's average global assessment of response to therapy through the final on-therapy visit | |||
Secondary | Average change from baseline to final on-therapy visit for WOMAC stiffness subscale score; average change from baseline to final on-therapy visit for total WOMAC Index; average number of propoxyphene HCl rescue medication capsules per day while in study |
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