NCT00137033

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 605 (planned)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Peptic Ulcers

Interventions

Type	Name	Description
DRUG	Celecoxib
DRUG	Naproxen
DRUG	ASA

Timeline

• Start date: 2004-09-01
• Completion: 2005-07-01
• First posted: 2005-08-29
• Last updated: 2021-03-03

Locations

23 sites across 1 country: United States