Status:
COMPLETED
An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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 osteoarthrit...
Detailed Description
This is a randomized, double-blind, placebo-controlled study to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day as compared with pla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
483 Patients enrolled
Trial Details
Trial ID
NCT00240786
Start Date
April 1 2002
End Date
March 1 2003
Last Update
June 29 2011
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