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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
605
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
...and 13 more locations
Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib 200 mg QD plus ASA 81 mg QD vs. naproxen 500 mg BID plus ASA 81 mg QD in healthy subjects (50-75 years old).
Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib plus ASA vs placebo plus ASA in healthy subjects (50-75 years of age) Compare the incidence of gastroduodenal endoscopic ulcers between naproxen plus ASA vs. placebo plus ASA
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