A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee

NCT00240773 | Completed Phase 3

• 1 other identifier: CR002197
• Study Type: interventional
• Target: 581
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the long-term safety and effectiveness of acetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment of osteoarthritis of the hip or knee.

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Keywords

osteoarthritis hip; osteoarthritis knee; acetaminophen, naproxen

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the WOMAC Osteoarthritis Index pain subscale score at Month 6 or at the final visit at the time of subject discontinuation from baseline during the first six months after baseline.

Secondary Outcomes (1)

• Change from baseline to Month 6 (or Month 12 for subjects participating in Group 1) or final visit in the WOMAC Osteoarthritis Index stiffness and physical function subscale scores.

Study Arms (4)

001

EXPERIMENTAL

acetaminophen 4 grams daily for 12 months

Drug: acetaminophen

002

ACTIVE COMPARATOR

naproxen 750 mg daily for 12 months

Drug: naproxen

003

EXPERIMENTAL

acetaminophen 4 grams daily for six months

Drug: acetaminophen

004

ACTIVE COMPARATOR

naproxen 750 mg daily for six months

Drug: naproxen

Interventions

acetaminophen DRUG

4 grams daily for six months

003

naproxen DRUG

750 mg daily for 12 months

002

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis of the hip or knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months
• History of osteoarthritis of the hip or knee characterized by pain of mild or moderate intensity
• Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
• Physical ability must be either American College of Rheumatology (ACR) Functional Class I or II
• Following the washout period, reports mild to moderately severe pain over the previous 24 hours and demonstrates a minimum increase of 20% in the WOMAC Osteoarthritis Index pain subscale score, relative to the screening score.

You may not qualify if:

• History of surgery, including arthroscopy, or major trauma to the study joint in the previous 12 months
• Radiographic evidence of severe osteoarthritis of the study joint based on the Kellgren and Lawrence radiographic criteria of grade 4 osteoarthritis
• Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period
• Morning stiffness of \>30 minutes duration
• Significantly incapacitated or disabled and would be categorized as ACR Functional Class III (able to perform only few or none of the duties of usual occupation or self-care) or IV (largely or wholly incapacitated), or unable to walk without assistive devices

Sponsors & Collaborators

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

Related Links

• A Safety and Effectiveness Study of Acetaminophen (4000 mg/day) and Naproxen (750 mg/day) in the Treatment of Osteoarthritis of the Hip or Knee

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Interventions

Acetaminophen; Naproxen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

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: June 1, 2003
• Last Updated: June 19, 2015

Record last verified: 2015-06