drugset / Trial / NCT05841394

A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Prevention of Stress Ulcer Bleeding

NCT05841394

Phase 3 Completed 449 enrolled Livzon Pharmaceutical Group Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of the study drug (Ilaprazole Sodium for Injection) for potential effect on preventing stress ulcer bleeding in vulnerable population by comparing the radio of upper gastrointestinal bleeding when they are administered Ilaprazole Sodium for Injection and Esomeprazole Sodium for Injection respectively.

Timeline

Start
2021-07-16
Primary completion
2022-04-28
Completion
2022-04-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 40 mg Intravenous
Subject Ilaprazole Small molecule 10 mg Intravenous

Indications