Official Title: “A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-Month Treatment of Subjects With Osteoarthritis of the Knee”

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • 200 mg oral capsule once daily for 6 months
• Drug: Naproxen
  • 500 mg oral capsule twice daily for 6 months
• Drug: Placebo
  • Matched oral placebo for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B
• Placebo Comparator: C

Primary Measures

• Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score
  • Time Frame: Month 6
    Safety Issue?: No

Secondary Measures

• Number of health care professional contacts
  • Time Frame: Throughout study
    Safety Issue?: No
• Patient's and Physician's Satisfaction with Current Arthritis Therapy
  • Time Frame: Month 6
    Safety Issue?: No
• Change in WOMAC Total Score from baseline
  • Time Frame: Month 6
    Safety Issue?: No
• Change in WOMAC Subscales from baseline
  • Time Frame: Month 6
    Safety Issue?: No
• Response in each WOMAC Subscale
  • Time Frame: Month 6
    Safety Issue?: No
• Change in Medical Outcome Study sleep scale from baseline
  • Time Frame: Month 6
    Safety Issue?: No
• Laboratory tests
  • Time Frame: Month 6
    Safety Issue?: Yes
• Vital signs
  • Time Frame: Month 6
    Safety Issue?: Yes
• Response in VAS
  • Time Frame: Month 6
    Safety Issue?: No
• Change in Patient's and Physician's Global Assessment of Pain from baseline
  • Time Frame: Month 6
    Safety Issue?: No
• Change in visual analog scale (VAS) from baseline
  • Time Frame: Month 6
    Safety Issue?: No
• Adverse events
  • Time Frame: Throughout study
    Safety Issue?: Yes
• Change in Gastrointestinal (GI) Distress Scale from Week 1
  • Time Frame: Month 6
    Safety Issue?: No
• Change in GI Distress Scale from time of discontinuation of study drug
  • Time Frame: Month 6
    Safety Issue?: No
• Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)
  • Time Frame: Throughout study
    Safety Issue?: No
• Number of hospitalizations, emergency room visits, and procedures
  • Time Frame: Throughout study
    Safety Issue?: No
• Change in Work Limitation Questionnaire scale scores from baseline
  • Time Frame: Month 6
    Safety Issue?: No
• Physical examination
  • Time Frame: Month 6
    Safety Issue?: Yes

Inclusion Criteria:

• Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
• Functional Capacity Classification of I-III

Exclusion Criteria:

• Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
• Received acetaminophen within 24 hours of the baseline visit
• Acute joint trauma at index joint within the past 3 months with active symptoms
• History of gastrointestinal (GI) perforation, obstruction, or bleeding
• Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
• Received corticosteroids or hyaluronic acid within certain timeframe before study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643799

Study ID Number: A3191152

ClinicalTrials.gov Identifier: NCT00643799

Health Authority: United States: Food and Drug Administration

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