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

PHASE3CompletedINTERVENTIONAL
Enrollment

449

Participants

Timeline

Start Date

July 16, 2021

Primary Completion Date

April 28, 2022

Study Completion Date

April 28, 2022

Conditions
Stress Ulcer Bleeding
Interventions
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.

Trial Locations (2)

200025

Shanghai Jiaotong University Affiliate Ruijin Hospital, Shanghai

Unknown

The First Affiliated Hopspital of Xinjiang Medical University, Ürümqi

All Listed Sponsors
lead

Livzon Pharmaceutical Group Inc.

INDUSTRY