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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
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 October 19, 2014