Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population

Condition(s) targeted: Peptic Ulcers

Intervention: Celecoxib (Drug); Naproxen (Drug); ASA (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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).

Official title: A Multicenter, Randomized, Active-Controlled Comparison Study of the Incidence of Gastroduodenal Ulcers Associated With Celecoxib and Low Dose ASA Versus Naproxen and Low Dose ASA in Healthy Subjects (50-75 Years of Age)

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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).

Secondary outcome: 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

Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, Anaheim, California 92801, United States

Pfizer Investigational Site, Farmington, Connecticut 06030-0001, United States

Pfizer Investigational Site, Waterbury, Connecticut 06708, United States

Pfizer Investigational Site, Ocoee, Florida 34761, United States

Pfizer Investigational Site, Pembroke Pines, Florida 33024, United States

Pfizer Investigational Site, Miami, Florida 33173, United States

Pfizer Investigational Site, Jupiter, Florida 33458, United States

Pfizer Investigational Site, Chicago, Illinois 60612-7323, United States

Pfizer Investigational Site, Newburgh, Indiana 47630, United States

Pfizer Investigational Site, Davenport, Iowa 52807, United States

Pfizer Investigational Site, Metaire, Louisiana 70001, United States

Pfizer Investigational Site, Chevy Chase, Maryland 20815, United States

Pfizer Investigational Site, New York, New York 10021, United States

Pfizer Investigational Site, Raleigh, North Carolina 27612, United States

Pfizer Investigational Site, Wilmington, North Carolina 28401, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Ducansville, Pennsylvania 16635, United States

Pfizer Investigational Site, Chattanooga, Tennessee 37404, United States

Pfizer Investigational Site, Houston, Texas 77074, United States

Pfizer Investigational Site, Houston, Texas 77090, United States

Pfizer Investigational Site, Chesapeake, Virginia 23320-1706, United States

Pfizer Investigational Site, Charlottesville, Virginia 22903, United States

Link to ClinicalStudyResults.org Posting

Starting date: September 2004
Ending date: July 2005
Last updated: September 19, 2007