A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee

NCT00568295 | Completed Phase 3

• 1 other identifier: 99-090
• Study Type: interventional
• Target: 403
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.

  Four Weeks

Secondary Outcomes (7)

• Change from Baseline in the WOMAC pain subscale score

  Weeks 1 and 2

• Change from baseline in the WOMAC stiffness and physical function subscale scores

  Weeks 1, 2 and 4

• Investigator's impression of therapeutic response

  Weeks 1, 2, and 4

• Subject's assessment of medication as an analgesic for the study knee joint

  Weeks 1, 2, and 4

• Daily pain intensity differences from baseline

  Week 1

Study Arms (3)

Acetaminophen

EXPERIMENTAL

Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP

Drug: acetaminophen

Refecoxib 12.5 mg

ACTIVE COMPARATOR

Rofecoxib: Capsules 12.5 mg, oral, C-904-1A

Drug: Rofecoxib

Rofecoxib 12.5 x 2

ACTIVE COMPARATOR

Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A

Drug: Rofecoxib

Interventions

acetaminophen DRUG

Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.

Also known as: Tylenol

Acetaminophen

Rofecoxib DRUG

Rofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.

Also known as: Viox

Refecoxib 12.5 mg

Eligibility Criteria

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

You may qualify if:

• Symptomatic idiopathic osteoarthritis of the 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.
• A history of osteoarthritis of the knee characterized by pain of at least a moderate intensity.
• Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
• Subjects' physical ability was to be either American College of Rheumatology (ACR) Function Class I or II
• At the baseline visit, subjects must have reported a maximum pain intensity experienced over the previous 24 hours of at least moderate on a five-point scale of none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be enrolled in the study.

You may not qualify if:

• Medical history, physical examinations, or radiographs suggestive of other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia.
• Medical or psychiatric conditions that may influence absorption, metabolism, or excretion of the study medications or interfere with interpretation of adverse reactions to the study drug.
• History of allergy, sensitivity, contraindication or non-response to acetaminophen, rofecoxib, or drugs classified as NSAIDs including aspirin.
• Use of concomitant medications that might interfere with study drug assessments, including intra-articular corticosteroids.
• Signs of active knee inflammation, morning stiffness of greater than 30 minutes duration.
• Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
• ACR functional class III or IV, or unable to walk without assistive devices.
• Pregnancy, lactation, or expect to become pregnant within one month of study completion.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acetaminophen; rofecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Edwin Kuffner, MD

  McNeil Consumer Healthcare USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: October 1, 1999
• Primary Completion: October 1, 2000
• Study Completion: October 1, 2000
• Last Updated: August 22, 2011

Record last verified: 2011-08