A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
- Registration Number
- NCT00568295
- Brief Summary
To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee
- Detailed Description
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 study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acetaminophen acetaminophen Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP Refecoxib 12.5 mg Rofecoxib Rofecoxib: Capsules 12.5 mg, oral, C-904-1A Rofecoxib 12.5 x 2 Rofecoxib Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A
- Primary Outcome Measures
Name Time Method Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population. Four Weeks
- Secondary Outcome Measures
Name Time Method Change from Baseline in the WOMAC pain subscale score Weeks 1 and 2 Change from baseline in the WOMAC stiffness and physical function subscale scores Weeks 1, 2 and 4 Investigator's impression of therapeutic response Weeks 1, 2, and 4 Subject's assessment of medication as an analgesic for the study knee joint Weeks 1, 2, and 4 Daily pain intensity differences from baseline Week 1 Investigator's global impression of therapeutic response Week 4 Subject's overall impression of the study medication Week 4