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

NCT03362281 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2017-12-06

No results posted yet for this study

Summary

The purpose of this phase study is to confirm the efficacy and safety by compare ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a multi-center, stratified randomized, non-inferiority test, 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. The primary endpoint was the hemostasis rate at the end of 72 hours. Secondary end points include ulcer staging changes within 72 hours, effective rate of hemostasis, hemostasis duration, average blood transfusion and rebleeding rate, etc.

Conditions

  • Peptic Ulcer Hemorrhage

Interventions

DRUG

Ilaprazole

10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling.

DRUG

Omeprazole

40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min.

DRUG

Ilaprazole tablet

Since 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day

DRUG

amoxicillin and clarithromycin

The Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks

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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

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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 NCT03362281 on ClinicalTrials.gov