An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee
Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: acetaminophen extended release (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Consumer and Personal Products Worldwide Official(s) and/or principal investigator(s): McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study Director, Affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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 outcome: 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
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 placebo, for the relief of signs and symptoms of osteoarthritis of the hip
or knee for a period of 12 weeks. Propoxyphene Hydrochloride capsules 65 mg are used as
rescue medication if subjects experience inadequate pain relief. The primary efficacy
assessments are the average change from baseline to the final on-therapy visit for the WOMAN
pain subscale score and the WOMAC physical function subscale scare, and the subject's
average global assessment of their response to therapy through the final on-therapy visit.
Safety assessments at study visits consist of monitoring adverse events, vital signs, study
joint assessments and clinical laboratory determinations. The hypothesis is that 1950 mg
per day and/or 3900 mg per day acetaminophen extended release are superior to placebo for
the relief of the signs and symptoms of osteoarthritis of the hip or knee with respect to
all three primary efficacy endpoints. Treatment consisted of either one 650 mg
acetaminophen extended release caplet plus one placebo caplet (acetaminophen 1950 mg group);
two 650 mg acetaminophen extended release caplets (acetaminophen 3900 mg group); or two
placebo caplets administered orally every eight hours for 12 weeks.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee
Starting date: April 2002
Last updated: June 28, 2011
|