An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets 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:
NCT00240799
First received: October 14, 2005
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks


Condition Intervention Phase
Osteoarthritis
Drug: acetaminophen extended release
Drug: placebo
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 (3900 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:
  • Average change from baseline through Week 12 for WOMAC pain subscale score. Average change from baseline through Week 12 for WOMAC physical function subscale score. Subject's average global assessment of response to therapy through Week 12.

Secondary Outcome Measures:
  • Average change from baseline through Week 12 for: WOMAC stiffness subscale score; total WOMAC Osteoarthritis Index; and Nottingham Health Profile Energy subscale score

Enrollment: 542
Study Completion Date: October 2004
Arms Assigned Interventions
Experimental: 001
acetaminophen extended release
Drug: acetaminophen extended release
Placebo Comparator: 002
placebo
Drug: placebo

Detailed Description:

This is a randomized, double-blind, placebo controlled study to evaluate acetaminophen extended release 3900 mg/day compared with placebo in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks. The hypothesis is that 3900 mg/day acetaminophen extended release is superior to placebo in the relief of signs and symptoms of osteoarthritis of the hip or knee with respect to the three primary effectiveness endpoints. 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 through Week 12 for the WOMAC pain subscale score and the WOMAC physical function subscale score, and the subject's average global assessment of their response to therapy through Week 12. Safety assessments at study visits consist of monitoring adverse events, vital signs, study joint assessments and clinical laboratory determinations. Treatment consists of two acetaminophen 650 mg extended release caplets or two placebo caplets, administered orally every 8 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:

  • Symptoms 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/week) for at least three months before the screening visit
  • History of positive benefit with acetaminophen use for osteoarthritis pain
  • History (ie, at any time in the past since diagnosis) of osteoarthritis pain of the hip or knee when not taking osteoarthritis analgesic medication
  • Subjects must report a history of a pain level of moderate, moderately severe, or severe, a WOMAC pain score >= 65 at baseline, and a 20% or greater increase in their pain score relative to their 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
  • 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
  • Secondary osteoarthritis of the study joint including, but not limited to, septic arthritis, inflammatory joint disease, gout, Paget's disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis
  • History of acute inflammatory arthritis or pseudogout of the study joint.
  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: NCT00240799

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 by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00240799     History of Changes
Other Study ID Numbers: CR002488
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

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

ClinicalTrials.gov processed this record on August 21, 2014