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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: acetaminophen; Drug: Rofecoxib; Drug: Rofecoxib

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.

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen; Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP	Drug: acetaminophen; 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.; Other Names: Tylenol
Active Comparator: Refecoxib 12.5 mg; Rofecoxib: Capsules 12.5 mg, oral, C-904-1A	Drug: Rofecoxib; 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.; Other Names: Viox; Drug: Rofecoxib; 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.; Other Names: Viox
Active Comparator: Rofecoxib 12.5 x 2; Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A	Drug: Rofecoxib; 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.; Other Names: Viox; Drug: Rofecoxib; 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.; Other Names: Viox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Edwin Kuffner, MD, McNeil Consumer Healthcare USA

Study record dates

Study Major Dates

• Study Start: October 1, 1999
• Primary Completion (Actual): October 1, 2000
• Study Completion (Actual): October 1, 2000

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 6, 2007

Study Record Updates

• Last Update Posted (Estimate): August 22, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Cyclooxygenase 2 Inhibitors; Acetaminophen; Rofecoxib
• Other Study ID Numbers: 99-090