Clinical trial NCT00568295: A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 403
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.
timeFrame: Four Weeks
Secondary outcomes:
measure: Change from Baseline in the WOMAC pain subscale score
timeFrame: Weeks 1 and 2
measure: Change from baseline in the WOMAC stiffness and physical function subscale scores
timeFrame: Weeks 1, 2 and 4
measure: Investigator's impression of therapeutic response
timeFrame: Weeks 1, 2, and 4
measure: Subject's assessment of medication as an analgesic for the study knee joint
timeFrame: Weeks 1, 2, and 4
measure: Daily pain intensity differences from baseline
timeFrame: Week 1
measure: Investigator's global impression of therapeutic response
timeFrame: Week 4
measure: Subject's overall impression of the study medication
timeFrame: Week 4
Other outcomes:
Locations:
Study officials:
affiliation: McNeil Consumer Healthcare USA
name: Edwin Kuffner, MD
role: STUDY_DIRECTOR
References: