Official Title: “A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen”

To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • 200 mg oral capsule once daily for 6 weeks
• Drug: Placebo
  • Matched oral placebo for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Placebo Comparator: B

Primary Measures

• Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
  • Time Frame: Week 6
    Safety Issue?: No

Secondary Measures

• Western Ontario and McMaster Universities Osteoarthritis Index
  • Time Frame: Week 6
    Safety Issue?: No
• Patient's and Physician's Global Assessment of Pain
  • Time Frame: Weeks 2 and 6
    Safety Issue?: No
• The Medical Outcomes Study Sleep Scale
  • Time Frame: Week 6
    Safety Issue?: No
• Adverse events
  • Time Frame: Weeks 0-6
    Safety Issue?: Yes
• Laboratory tests
  • Time Frame: Week 6
    Safety Issue?: Yes
• Vital signs
  • Time Frame: Week 6
    Safety Issue?: Yes
• Physical examination
  • Time Frame: Week 6
    Safety Issue?: Yes
• Patient's Assessment of Arthritis Pain according to VAS
  • Time Frame: Week 2
    Safety Issue?: No
• Serious adverse events
  • Time Frame: Up to 30 days after last dose
    Safety Issue?: Yes

Inclusion criteria:

• OA of the knee in flare state at baseline visit and functional capacity class of I-III
• Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion criteria:

• Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
• Received acetaminophen within 24 hours of baseline visit
• Use of mobility assisting device for less than six weeks prior to study screening or use of a walker
• History of gastrointestinal (GI) perforation, obstruction, or bleeding
• Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
• Recieved 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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640627

Study ID Number: A3191069

ClinicalTrials.gov Identifier: NCT00640627

Health Authority: United States: Food and Drug Administration

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