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

NCT00240786 | Completed Phase 3

• 1 other identifier: CR002485
• Study Type: interventional
• Target: 483
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

osteoarthritis hip; osteoarthritis knee; acetaminophen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

acetaminophen extended release DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Related Publications (1)

• Kuffner EK, Temple AR, Cooper KM, Baggish JS, Parenti DL. Retrospective analysis of transient elevations in alanine aminotransferase during long-term treatment with acetaminophen in osteoarthritis clinical trials. Curr Med Res Opin. 2006 Nov;22(11):2137-48. doi: 10.1185/030079906x148346.

  PMID: 17076974 DERIVED

Related Links

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

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: April 1, 2002
• Study Completion: March 1, 2003
• Last Updated: June 29, 2011

Record last verified: 2011-06