Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
Completed · Phase 4
Conditions studied: Peptic Ulcers
In brief
The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).
Key facts
- Study ID
- NCT00137033
- Run by
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- People needed
- 605
- Starts
- 2004-09-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2021-03-03
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- A healthy adult between 50 and 75 years of age inclusive: of normal clinical laboratory test results during the Screening Visit or, if abnormal, are not clinically significant in the Investigator's opinion.
You may not qualify if…
- A gastric, pyloric channel or duodenal ulcer (defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than 5 erosions in the stomach or duodenum ( the UGI endoscopic score greater or less) on the baseline UGI endoscopy
Where it is running
- Pfizer Investigational Site — Anaheim, California, United States
- Pfizer Investigational Site — San Diego, California, United States
- Pfizer Investigational Site — Farmington, Connecticut, United States
- Pfizer Investigational Site — Waterbury, Connecticut, United States
- Pfizer Investigational Site — Jupiter, Florida, United States
- Pfizer Investigational Site — Miami, Florida, United States
- Pfizer Investigational Site — Ocoee, Florida, United States
- Pfizer Investigational Site — Pembroke Pines, Florida, United States
- Pfizer Investigational Site — Chicago, Illinois, United States
- Pfizer Investigational Site — Newburgh, Indiana, United States
- Pfizer Investigational Site — Davenport, Iowa, United States
- Pfizer Investigational Site — Metairie, Louisiana, United States
- Pfizer Investigational Site — Chevy Chase, Maryland, United States
- Pfizer Investigational Site — New York, New York, United States
- Pfizer Investigational Site — Raleigh, North Carolina, United States
- Pfizer Investigational Site — Wilmington, North Carolina, United States
- Pfizer Investigational Site — Cincinnati, Ohio, United States
- Pfizer Investigational Site — Duncansville, Pennsylvania, United States
- Pfizer Investigational Site — Chattanooga, Tennessee, United States
- Pfizer Investigational Site — Houston, Texas, United States
- Pfizer Investigational Site — Houston, Texas, United States
- Pfizer Investigational Site — Charlottesville, Virginia, United States
- Pfizer Investigational Site — Chesapeake, Virginia, United States
Full record on ClinicalTrials.gov
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