Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus Celecoxib

Phase 3 Completed 273 enrolled Chinese University of Hong Kong

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the effect of Esomeparzole with Placebo in the Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor

Timeline

Start: 2002-08
Primary completion: —
Completion: 2005-06

Outcome

Met primary endpoint

paper Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. PMID 17499604 ↗

paper The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8.9%) in the controls PMID 17499604 ↗

Publications

Chan FK, Wong VW, Suen BY, Wu JC, Ching JY, Hung LC, Hui AJ, Leung VK, Lee VW, Lai LH, Wong GL, Chow DK, To KF, Leung WK, Chiu PW, Lee YT, Lau JY, Chan HL, Ng EK, Sung JJ. Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial. Lancet. 2007 May 12;369(9573):1621-6. doi: 10.1016/S0140-6736(07)60749-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esomeprazole	Small molecule	20 mg	—
Background	Celecoxib	Other / unclassified	200 mg	—