A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
Information source: Johnson & Johnson Consumer & Personal Products Worldwide
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis of the Knee
Intervention: acetaminophen (Drug); Rofecoxib (Drug); Rofecoxib (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Consumer & Personal Products Worldwide
Official(s) and/or principal investigator(s):
Edwin Kuffner, MD, Study Director, Affiliation: McNeil Consumer Healthcare USA
To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis
of the Knee
Official title: A Four-Week Comparative Study Evaluating Acetaminophen Extended Release (3900 mg/Day) and Rofecoxib (12.5 mg/Day and 25 mg/Day)in the Treatment of Osteoarthritis of the Knee
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.
Change from Baseline in the WOMAC pain subscale score
Change from baseline in the WOMAC stiffness and physical function subscale scores
Investigator's impression of therapeutic response
Subject's assessment of medication as an analgesic for the study knee joint
Daily pain intensity differences from baseline
Investigator's global impression of therapeutic response
Subject's overall impression of the study medication
An initial screening visit was performed in order to assess subject medical history and the
potential eligibility of subjects. Following the initial screening visit, all potential
subjects underwent a washout period from their usual arthritis medication and returned to the
study center for a baseline visit to verify their eligibility.
At the completion of the baseline visit, all eligible subjects were randomly assigned to a
treatment group and instructed on the dosing regimen for their assigned study medication.
Subjects returned to the study center for follow-up visits after Week 1 and Week 2 of
treatment and a final visit after Week 4 of treatment or upon discontinuation from the
Minimum age: 40 Years.
Maximum age: N/A.
- Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration
requiring treatment with either an analgesic or anti-inflammatory agent on a regular
basis (greater than or equal to three days/week) for at least three months.
- A history of osteoarthritis of the knee characterized by pain of at least a moderate
- Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the
Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
- Subjects' physical ability was to be either American College of Rheumatology (ACR)
Function Class I or II
- At the baseline visit, subjects must have reported a maximum pain intensity
experienced over the previous 24 hours of at least moderate on a five-point scale of
none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be
enrolled in the study.
- Medical history, physical examinations, or radiographs suggestive of other types of
arthritis, pseudogout, collagen vascular disease or fibromyalgia.
- Medical or psychiatric conditions that may influence absorption, metabolism, or
excretion of the study medications or interfere with interpretation of adverse
reactions to the study drug.
- History of allergy, sensitivity, contraindication or non-response to acetaminophen,
rofecoxib, or drugs classified as NSAIDs including aspirin.
- Use of concomitant medications that might interfere with study drug assessments,
including intra-articular corticosteroids.
- Signs of active knee inflammation, morning stiffness of greater than 30 minutes
- Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren
erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
- ACR functional class III or IV, or unable to walk without assistive devices.
- Pregnancy, lactation, or expect to become pregnant within one month of study
Locations and Contacts
Starting date: October 1999
Ending date: October 2000
Last updated: March 27, 2008