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

NCT00240799 | Completed Phase 3

• 1 other identifier: CR002488
• Study Type: interventional
• Target: 542
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis

Keywords

osteoarthritis hip; osteoarthritis knee; acetaminophen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Study Arms (2)

001

EXPERIMENTAL

acetaminophen extended release

Drug: acetaminophen extended release

002

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

acetaminophen extended release DRUG

001

placebo DRUG

002

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator

Related Publications (2)

• Prior MJ, Harrison DD, Frustaci ME. A randomized, double-blind, placebo-controlled 12 week trial of acetaminophen extended release for the treatment of signs and symptoms of osteoarthritis. Curr Med Res Opin. 2014 Nov;30(11):2377-87. doi: 10.1185/03007995.2014.949646. Epub 2014 Aug 14.

  PMID: 25121804 DERIVED

• 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 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Completion: October 1, 2004
• Last Updated: June 19, 2015

Record last verified: 2015-06