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

Intervention(s) in this Clinical Trial

• Drug: Ibuprofen
  • 800 mg oral tablet 3 times daily with meals for 6 weeks
• Drug: Placebo
  • Matched placebo orally for 6 weeks
• Drug: Celecoxib
  • 200 mg oral capsule once daily with morning meal for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

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

Secondary Measures

• Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores
  • Time Frame: Days 1-7
    Safety Issue?: No
• Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
  • Time Frame: Week 2
    Safety Issue?: No
• Change from baseline in patient and physician global assessments of arthritis
  • Time Frame: Weeks 2 and 6
    Safety Issue?: No
• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
  • Time Frame: Week 6
    Safety Issue?: No
• The Pain Satisfaction Scale
  • Time Frame: Week 6
    Safety Issue?: No
• The Patient Health Questionnaire (PHQ-9)
  • Time Frame: Week 6
    Safety Issue?: No
• Measurement of upper gastrointestinal tolerability
  • Time Frame: Weeks 2 and 6
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Weeks 2 and 6
    Safety Issue?: Yes
• Laboratory test results
  • Time Frame: Week 6
    Safety Issue?: Yes
• Vital signs
  • Time Frame: Weeks 2 and 6
    Safety Issue?: Yes
• Physical examination
  • Time Frame: Week 6
    Safety Issue?: Yes

Inclusion Criteria:

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:

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 November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630929

Study ID Number: A3191062

ClinicalTrials.gov Identifier: NCT00630929

Health Authority: United States: Food and Drug Administration

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