An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Acetaminophen

Criteria

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