NCT03362281

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

Efficacy and Safety of Intravenous IIaprazole for Peptic Ulcer Bleeding: A Randomized, Double-Blind, Omeprazole-Controlled, Multicenter, and Phase 3 Trail in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with endoscopically diagnosed gastric and duodenal ulcer bleeding were randomly assigned into two groups, ilaprazole and omeprazole. 360 patients were administrated 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Other 180 patients were administrated 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion for 30min. Since 4th day, both group taken oral ilaprazole tablets 10mg each day till 30th day; And the Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks. The efficacy of ilaprazole and omeprazole was evaluated by the primary endpointthe-hemostasis rate at the end of 72 hours in the total population, high-risk groups and low-risk groups and secondary end points including ulcer staging changes within 72 hours, effective rate of hemostasis, hemostasis duration, average blood transfusion, the need to switch to other treatments (endoscopic treatment or surgery, etc.), the disappearance time of ulcer pain and rebleeding rate. This phase Ⅲ clinical trial was designed to confirm the efficacy and safety of ilaprazole in the treatment of peptic ulcer bleeding and to pride a basis for registration.

Conditions

• Peptic Ulcer Hemorrhage

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2017-12-05
• Last updated: 2017-12-06