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

Completed · Phase 4

Conditions studied: Osteoarthritis

In brief

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

Key facts

Study ID

NCT00373685

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

8067

Starts

2006-10-01

Expected to finish

2010-11-01

Last updated by the study team

2021-03-03

Who can join

Age: 55 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Alexander City, Alabama, United States
• Pfizer Investigational Site — Bay Minette, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Cullman, Alabama, United States
• Pfizer Investigational Site — Dothan, Alabama, United States
• Pfizer Investigational Site — Dothan, Alabama, United States
• Pfizer Investigational Site — Geneva, Alabama, United States
• Pfizer Investigational Site — Gulf Shores, Alabama, United States
• Pfizer Investigational Site — Guntersville, Alabama, United States
• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Jacksonville, Alabama, United States
• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Montgomery, Alabama, United States
• Pfizer Investigational Site — Muscle Shoals, Alabama, United States
• Pfizer Investigational Site — Ozark, Alabama, United States
• Pfizer Investigational Site — Pell City, Alabama, United States
• Pfizer Investigational Site — Tallassee, Alabama, United States
• Pfizer Investigational Site — Chandler, Arizona, United States
• Pfizer Investigational Site — Abbeville, Alabama, United States

Full record on ClinicalTrials.gov

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