Official Title: “Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients”

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety Study

Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

• Drug: Any commercially available NSAID with the indication for osteoarthritis
  • dosing as per USPI label related to the chosen commercially marketed NSAID
• Drug: Celecoxib
  • open-label

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: NSAIDs
• Experimental: Celecoxib
  • dosing as per USPI label

Primary Measures

• The primary endpoint of this study is the incidence of clinically significant upper and/or lower GI events.
  • Time Frame: 6 months
    Safety Issue?: Yes

Secondary Measures

• The Efficacy Subscale of the Satisfaction with Current Pain Medication Scale of the PTSS as the secondary measure of patient satisfaction, nsNSAID and celecoxib utilization, Non-study drug utilization,PPI and other gastro-protective drug utilization.
  • Time Frame: 6 months
    Safety Issue?: No
• Incidence of fecal occult blood positivity at study termination.
  • Time Frame: 6 months
    Safety Issue?: Yes
• Incidence of: Moderate to severe abdominal symptoms and withdrawal due to GI AEs,
  • Time Frame: 6 months
    Safety Issue?: Yes
• Change in Hb and Hct from Baseline to Study Termination visit
  • Time Frame: 6 months
    Safety Issue?: Yes
• Outcomes Research secondary endpoints
  • Time Frame: 6 months
    Safety Issue?: No
• Safety secondary endpoints
  • Time Frame: 6 months
    Safety Issue?: Yes
• Patient satisfaction with celecoxib compared to nsNSAID therapy as measured by a Drug Satisfaction With Pain Medication Question as the primary measure of patient satisfaction
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion Criteria:

• GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
• Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00373685

Study ID Number: A3191331

ClinicalTrials.gov Identifier: NCT00373685

Health Authority: United States: Food and Drug Administration

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