GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
  • Time Frame: Baseline through week 24 or Early Termination (ET)
    Safety Issue?: Yes

Secondary Measures

• Percentage of Participants With Moderate to Severe Abdominal Symptoms
  • Time Frame: Baseline through week 24 or ET
    Safety Issue?: Yes
• Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)
  • Time Frame: Baseline through week 24 or ET
    Safety Issue?: Yes
• Hemoglobin (Hb) at Baseline
  • Time Frame: Baseline
    Safety Issue?: No
• Change From Baseline Hb at Week 24
  • Time Frame: Baseline and Week 24 or ET
    Safety Issue?: Yes
• Hematocrit (Hct) at Baseline
  • Time Frame: Baseline
    Safety Issue?: No
• Change From Baseline Hct at Week 24
  • Time Frame: Week 24 or ET
    Safety Issue?: Yes
• Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline
  • Time Frame: Baseline, Weeks 8, 16, 24 or ET
    Safety Issue?: Yes
• Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall
  • Time Frame: Baseline, Weeks 8, 16, 24 or ET
    Safety Issue?: No
• Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief
  • Time Frame: Baseline, Weeks 8, 16, 24 or ET
    Safety Issue?: No
• Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief
  • Time Frame: Baseline, Weeks 8, 16, 24 or ET
    Safety Issue?: No
• Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief
  • Time Frame: Baseline, Weeks 8, 16, 24 or ET
    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?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

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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