Official Title: “Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-Inflammatory Medication for Control Of Their Pain”

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed.
• Drug: Celecoxib
  • 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Celecoxib - Continuous use
• Active Comparator: Celecoxib - Intermittent use

Primary Measures

• Number of Flare Events Per Time of Exposure to Study Medication
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No

Secondary Measures

• Time to Occurrence of First Osteoarthritis (OA) Flare
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Proportion of Days Free From Osteoarthritis (OA) Flare
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Proportion of Days in Osteoarthritis (OA) Flare
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Arthritis Pain Numerical Rating Scale (NRS)
  • Time Frame: Period III
    Safety Issue?: No
• Patient's Global Assessment of Arthritis
  • Time Frame: Period III
    Safety Issue?: No
• Physician's Global Assessment of Arthritis at Final Visit
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Total Rescue Medication Taken (Mean)
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Proportion of Days on Rescue Medication
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Days on Flare Medication
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No
• Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
  • Time Frame: Period III (22 weeks)
    Safety Issue?: No

Inclusion Criteria:

• Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Exclusion Criteria:

• Subject has had surgery on index joint.
• Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
• Subject has active gastrointestinal or cardiovascular disease.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

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 March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139776

Study ID Number: A3191173

ClinicalTrials.gov Identifier: NCT00139776

Health Authority: United States: Food and Drug Administration

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