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

A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Treatment of Prevention of Stress Ulcer Bleeding (Ilaprazole i.v. vs Esomeprazole, i.v.)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Ulcer Bleeding

Interventions

Type	Name	Description
DRUG	Esomeprazole 40mg	40 mg i.v. twice daily (q12h)
DRUG	Ilaprazole Sodium	10 mg i.v. once daily, 20 mg i.v. in the first day.
DRUG	Placebo 1	Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h.
DRUG	Placebo 2	Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day.

Timeline

• Start date: 2021-07-16
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2023-05-03
• Last updated: 2023-05-03

Locations

2 sites across 1 country: China