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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.
First Received: October 14, 2005   Last Updated: May 11, 2007   History of Changes
Sponsored by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier: NCT00240799
  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
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Estimated Enrollment: 520
Estimated Study Completion Date: October 2004
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 priamry 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
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 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 National Clinical Trials Identifier (NCT ID):
Study ID Numbers: CR002488
Study First Received: October 14, 2005
Last Updated: May 11, 2007
ClinicalTrials.gov Identifier: NCT00240799     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Osteoarthritis, Knee
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Osteoarthritis
Joint Diseases
Arthritis
Peripheral Nervous System Agents
Analgesics
Rheumatic Diseases
Osteoarthritis, Hip
Acetaminophen

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

ClinicalTrials.gov processed this record on September 10, 2009