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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00568295
First received: December 4, 2007
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: acetaminophen
Drug: Rofecoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome 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 ] [ Designated as safety issue: No ]

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

Enrollment: 403
Study Start Date: October 1999
Study Completion Date: October 2000
Primary Completion Date: October 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 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 Name: Viox

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568295

Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Edwin Kuffner, MD McNeil Consumer Healthcare USA
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00568295     History of Changes
Other Study ID Numbers: 99-090
Study First Received: December 4, 2007
Last Updated: August 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Rofecoxib
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014