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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2023-05-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841394 on ClinicalTrials.gov