drugset / Trial / NCT03362268

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

NCT03362268

Phase 2 Completed 180 enrolled Livzon Pharmaceutical Group Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a randomized, 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 and be seen at day 3, 4, 7, 14 and 30. The primary endpoint was the hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate ( bleeding groups with endoscopy check) within 72 hours. Secondary end points include effective rate of hemostasis, mean volume of blood transfusion, the length of stay and re-bleeding rate, etc.

Timeline

Start
2014-02
Primary completion
2014-06
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ilaprazole Small molecule 10 mg Intravenous
Comparator Omeprazole Other / unclassified 20 mg Intravenous

Indications