drugset / Trial / NCT00153660

Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients

NCT00153660

Phase 3 Completed 514 enrolled Chinese University of Hong Kong
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to compare celecoxib plus a PPI (esomeprazole) versus naproxen plus a PPI (esomeprazole) in preventing recurrent ulcer bleeding in arthritis patients with a history of ulcer bleeding who require concomitant ASA. We hypothesized that among patients with a history of ulcer bleeding who require concomitant ASA, celecoxib plus esomprazole would be superior to naproxen plus esomeprazole for the prevention of recurrent ulcer bleeding.

Timeline

Start
2005-06
Primary completion
2014-11
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 100 mg Oral
Comparator Naproxen Small molecule 500 mg Oral