Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 4
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.