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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2000

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Acetaminophen
  • Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP
• Active Comparator: Refecoxib 12.5 mg
  • Rofecoxib: Capsules 12.5 mg, oral, C-904-1A
• Active Comparator: Rofecoxib 12.5 x 2
  • Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Change from Baseline in the WOMAC pain subscale score
  • Time Frame: Weeks 1 and 2
    Safety Issue?: No
• Change from baseline in the WOMAC stiffness and physical function subscale scores
  • Time Frame: Weeks 1, 2 and 4
    Safety Issue?: No
• Investigator's impression of therapeutic response
  • Time Frame: Weeks 1, 2, and 4
    Safety Issue?: No
• Subject's assessment of medication as an analgesic for the study knee joint
  • Time Frame: Weeks 1, 2, and 4
    Safety Issue?: No
• Daily pain intensity differences from baseline
  • Time Frame: Week 1
    Safety Issue?: No
• Investigator's global impression of therapeutic response
  • Time Frame: Week 4
    Safety Issue?: No
• Subject's overall impression of the study medication
  • Time Frame: Week 4
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Consumer & Personal Products Worldwide

Overall Clinical Trial Officials and Contacts

Edwin Kuffner, MD Study Director McNeil Consumer Healthcare USA  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568295

Study ID Number: 99-090

ClinicalTrials.gov Identifier: NCT00568295

Health Authority: United States: Food and Drug Administration