drugset / Trial / NCT03675672

Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

NCT03675672

Phase 4 Recruiting 154 enrolled Chinese University of Hong Kong
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Patients with a history of idiopathic gastroduodenal ulcer bleeding face an increased risk of recurrent ulcer gastrointestinal bleeding. Our ongoing clinical trial demonstrates a possible reduced risk of recurrent idiopathic gastroduodenal ulcer bleeding with proton pump inhibitor (PPI), yet there is a significant risk of recurrent ulcer bleeding as PPI may increase the risk of small bowel bleeding. Our preliminary data provide strong plausibility that a combination therapy of misoprostol (MISO) with a PPI reduces the recurrent ulcer bleeding as well as clinical gastrointestinal bleeding. The investigators are going to provide the definitive answer to this important clinical question through a randomised trial.

Timeline

Start
2018-06-21
Primary completion
2026-12-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Misoprostol Other / unclassified 200 ug Oral