An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00240786
First received: October 14, 2005
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks.


Condition Intervention Phase
Osteoarthritis
Drug: acetaminophen extended release
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, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (1950 mg/Day or 3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Average change from baseline to the final on-therapy visit for - WOMAC pain subscale score; WOMAC physical function subscale score; and subject's average global assessment of response to therapy through the final on-therapy visit

Secondary Outcome Measures:
  • Average change from baseline to final on-therapy visit for WOMAC stiffness subscale score; average change from baseline to final on-therapy visit for total WOMAC Index; average number of propoxyphene HCl rescue medication capsules per day while in study

Enrollment: 483
Study Start Date: April 2002
Study Completion Date: March 2003
Detailed Description:

This is a randomized, double-blind, placebo-controlled study to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day as compared with placebo, for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks. Propoxyphene Hydrochloride capsules 65 mg are used as rescue medication if subjects experience inadequate pain relief. The primary efficacy assessments are the average change from baseline to the final on-therapy visit for the WOMAN pain subscale score and the WOMAC physical function subscale scare, and the subject's average global assessment of their response to therapy through the final on-therapy visit. Safety assessments at study visits consist of monitoring adverse events, vital signs, study joint assessments and clinical laboratory determinations. The hypothesis is that 1950 mg per day and/or 3900 mg per day acetaminophen extended release are superior to placebo for the relief of the signs and symptoms of osteoarthritis of the hip or knee with respect to all three primary efficacy endpoints. Treatment consisted of either one 650 mg acetaminophen extended release caplet plus one placebo caplet (acetaminophen 1950 mg group); two 650 mg acetaminophen extended release caplets (acetaminophen 3900 mg group); or two placebo caplets administered orally every eight hours for 12 weeks.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomats of osteoarthritis of the hip or knee for a minimum of six months
  • History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs, acetaminophen, or another analgesic agent on a regular basis (>= three days per week) for at least three months before the screening visit
  • History of positive therapeutic benefit with acetaminophen use for osteoarthritis pain
  • History of osteoarthritis pain (moderate, moderately severe, or severe) of the hip or knee when not taking osteoarthritis analgesic medication
  • Must have a pain level of moderate or moderately severe for 24 hours over the previous 24 hours prior to the baseline visit, and at baseline, demonstrate a 20% or greater increase in the pain subscale score, relative to the score at screening

Exclusion Criteria:

  • History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
  • Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence radiographic criteria
  • Maximum osteoarthritis pain intensity of none, mild or severe experienced over the previous 24 hours of the baseline visit
  • Signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
  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: NCT00240786

Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
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 by Johnson & Johnson Consumer and Personal Products Worldwide

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00240786     History of Changes
Other Study ID Numbers: CR002485
Study First Received: October 14, 2005
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
osteoarthritis hip
osteoarthritis knee
acetaminophen

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014