A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee

This study has been completed.
Sponsor:
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier:
NCT00240773
First received: October 14, 2005
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to compare the long-term safety and effectiveness of acetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment of osteoarthritis of the hip or knee.


Condition Intervention Phase
Osteoarthritis, Hip
Osteoarthritis, Knee
Drug: acetaminophen
Drug: naproxen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Long-Term Comparative Study Evaluating the Safety and Efficacy of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee

Resource links provided by NLM:


Further study details as provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

Primary Outcome Measures:
  • Change from baseline in the WOMAC Osteoarthritis Index pain subscale score at Month 6 or at the final visit at the time of subject discontinuation from baseline during the first six months after baseline.

Secondary Outcome Measures:
  • Change from baseline to Month 6 (or Month 12 for subjects participating in Group 1) or final visit in the WOMAC Osteoarthritis Index stiffness and physical function subscale scores.

Enrollment: 581
Study Completion Date: June 2003
Arms Assigned Interventions
Experimental: 001
acetaminophen 4 grams daily for 12 months
Drug: acetaminophen
4 grams daily for 12 months
Active Comparator: 002
naproxen 750 mg daily for 12 months
Drug: naproxen
750 mg daily for 12 months
Experimental: 003
acetaminophen 4 grams daily for six months
Drug: acetaminophen
4 grams daily for six months
Active Comparator: 004
naproxen 750 mg daily for six months
Drug: naproxen
750 mg daily for six months

Detailed Description:

This is a randomized, double-blind study to compare the long term safety profile and effectiveness of acetaminophen, given at a dose of 1000 mg every four to six hours, and naproxen, given at a dose of 375 mg twice daily (with matching placebo given four times daily to maintain the blind), in the treatment of osteoarthritis of the hip or knee. There are two groups of subjects. Group 1 has approximately 480 subjects randomized and a treatment duration of 12 months. Group 2 has approximately 80 subjects randomized and a treatment duration of 6 months. The primary measure of efficacy is the change from baseline in the WOMAC Osteoarthritis Index pain subscale at month 6. Safety evaluations, throughout the course of the study, include monitoring adverse events, laboratory tests and assessments of vital signs including respiration rate, pulse, blood pressure, and body weight. Subjects are instructed to take a dose of medication orally, every 4-6 hours. The acetaminophen subjects take a total daily dose of 4 g of acetaminophen. The naproxen subjects a total daily dose of 750 mg of naproxen. The treatment duration is 12 and 6 months in Group 1 and Group 2, respectively.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the hip or 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
  • History of osteoarthritis of the hip or knee characterized by pain of mild or moderate intensity
  • Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
  • Physical ability must be either American College of Rheumatology (ACR) Functional Class I or II
  • Following the washout period, reports mild to moderately severe pain over the previous 24 hours and demonstrates a minimum increase of 20% in the WOMAC Osteoarthritis Index pain subscale score, relative to the screening score.

Exclusion Criteria:

  • History of surgery, including arthroscopy, or major trauma to the study joint in the previous 12 months
  • Radiographic evidence of severe osteoarthritis of the study joint based on the Kellgren and Lawrence radiographic criteria of grade 4 osteoarthritis
  • Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period
  • Morning stiffness of >30 minutes duration
  • Significantly incapacitated or disabled and would be categorized as ACR Functional Class III (able to perform only few or none of the duties of usual occupation or self-care) or IV (largely or wholly incapacitated), or unable to walk without assistive devices
  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: NCT00240773

Sponsors and Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Study Director: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00240773     History of Changes
Other Study ID Numbers: CR002197
Study First Received: October 14, 2005
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:
osteoarthritis hip
osteoarthritis knee
acetaminophen, naproxen

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

ClinicalTrials.gov processed this record on July 24, 2014