drugset / Trial / NCT03362281

Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients

NCT03362281

Phase 3 Completed 540 enrolled Livzon Pharmaceutical Group Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this phase study is to confirm the efficacy and safety by compare ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a multi-center, stratified randomized, non-inferiority test, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, ilaprazole and omeprazole, to be treated for up to 30 days. The primary endpoint was the hemostasis rate at the end of 72 hours. Secondary end points include ulcer staging changes within 72 hours, effective rate of hemostasis, hemostasis duration, average blood transfusion and rebleeding rate, etc.

Timeline

Start
2014-10
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ilaprazole Small molecule 10 mg Intravenous
Comparator Omeprazole Other / unclassified 40 mg Intravenous
Background Amoxicillin Other / unclassified
Background Clarithromycin Small molecule