Status:
COMPLETED
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
55-99 years
Phase:
PHASE4
Brief Summary
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
8067 Patients enrolled
Trial Details
Trial ID
NCT00373685
Start Date
October 1 2006
End Date
November 1 2010
Last Update
March 3 2021
Active Locations (777)
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1
Pfizer Investigational Site
Abbeville, Alabama, United States, 36310
2
Pfizer Investigational Site
Alexander City, Alabama, United States, 35010
3
Pfizer Investigational Site
Bay Minette, Alabama, United States, 36507-4185
4
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205