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

Johnson & Johnson Consumer and Personal Products Worldwide403 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

403

Conditions

Osteoarthritis of the Knee

Interventions

acetaminophenDRUG

Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.

RofecoxibDRUG

Rofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.

RofecoxibDRUG

Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.

Time frame: Four Weeks

Secondary Outcomes

Change from Baseline in the WOMAC pain subscale score

Time frame: Weeks 1 and 2

Change from baseline in the WOMAC stiffness and physical function subscale scores

Time frame: Weeks 1, 2 and 4

Investigator's impression of therapeutic response

Time frame: Weeks 1, 2, and 4

Subject's assessment of medication as an analgesic for the study knee joint

Time frame: Weeks 1, 2, and 4

Daily pain intensity differences from baseline

Time frame: Week 1

Investigator's global impression of therapeutic response

Time frame: Week 4

Subject's overall impression of the study medication

Time frame: Week 4

Data from ClinicalTrials.gov

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