A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2000-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee

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

Details

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

Criteria

Inclusion Criteria:

• 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 intensity.

• 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.

Exclusion Criteria:

• 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 duration.

• 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 completion.