Official Title: “A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee”

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Study Type: Interventional

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

Study Primary Completion Date: March 2003

Intervention(s) in this Clinical Trial

• Drug: Ibuprofen
  • 800 mg oral tablet three time daily with meals for 6 weeks
• Drug: celecoxib
  • 200 mg oral capsule once daily with morning meal for 6 weeks
• Other: placebo
  • matched placebo orally for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ibuprofen
• Experimental: Celecoxib
• Placebo Comparator: placebo

Primary Measures

• Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)
  • Time Frame: Week 6
    Safety Issue?: No

Secondary Measures

• Vital signs
  • Time Frame: Weeks 2 and 6
    Safety Issue?: Yes
• Physical examination
  • Time Frame: Week 6
    Safety Issue?: Yes
• Laboratory test results
  • Time Frame: Week 6
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Weeks 2 and 6
    Safety Issue?: Yes
• Change from baseline in patient's and physician's global assessment of pain
  • Time Frame: Weeks 2 and 6
    Safety Issue?: No
• Pain Satisfaction Scale
  • Time Frame: Days 1-7
    Safety Issue?: No
• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
  • Time Frame: Week 6
    Safety Issue?: No
• Patient Health Questionnaire (PHQ-9)
  • Time Frame: Week 6
    Safety Issue?: No
• Change from baseline in patient's assessment of arthritis pain according to VAS
  • Time Frame: Week 2
    Safety Issue?: No

Inclusion Criteria:

• Aged >= 40 years old
• Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
• Functional capacity class of I-III

Exclusion Criteria:

• Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
• Acute joint trauma at index joint within the past 3 months with active symptoms
• Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
• Use of mobility assisting device for <6 weeks or use of walker

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620867

Study ID Number: A3191063

ClinicalTrials.gov Identifier: NCT00620867

Health Authority: United States: Food and Drug Administration

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