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

Primary Purpose

Peptic Ulcer Hemorrhage

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ilaprazole

Omeprazole

Ilaprazole tablet

amoxicillin and clarithromycin

About this trial

This is an interventional treatment trial for Peptic Ulcer Hemorrhage focused on measuring Peptic ulcer hemorrhage, Proton Pump Inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

were 18-70 years of age, male or female.
had symptoms of hematemesis, hematochezia, melena within 24 hours and clinically diagnosed as peptic ulcer bleeding.
had endoscopically diagnosed gastric or duodenal ulcer bleeding and 3mm ≤ ulcer diameter ≤ 15mm.
underwent local hemostasis according to "Acute non-variceal upper gastrointestinal bleeding guidelines (2009, Hangzhou)" Forrest grading; multiple ulcers was judged by the higher level.
voluntarily sign informed consent

Exclusion Criteria:

had hemorrhagic shock ( systolic blood pressure<90mmHg) or require surgery.
were non-ulcer bleeding and gastric ulcer biopsy proved malignant.
had gastrectomy and gastrointestinal anastomosis.
were suffering from serious heart, liver, brain, lung, kidney and other serious diseases.
had coagulation disorders (laboratory tests showed that platelets <80 × 109 / L, PT abnormal and exceed the normal control for 3 seconds, APTT than the normal control for 10 seconds).
had hypersensitivity or idiosyncratic reaction to ilaprazole, omeprazole, esomeprazole or any other benzimidazole.
had positive result of urine pregnancy test.
used the same kind of drugs within 48 hours before entering the group.
need to continue the combination of the following drugs that have an effect on treatment during the study: NSAIDs, corticosteroids, heparin, warfarin and vitamin K, platelet antagonists or other hemostatic agents.
participated in a clinical trial with an investigational drug or device within the past three months.
had alcoholic intemperance, drug addiction or other factors that researchers think it unfit for drug clinical trials.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ilaprazole

omeprazole

Arm Description

Outcomes

Primary Outcome Measures

the rate of hemostasis

the hemostasis rate checked by endoscopy within 72 hours

Secondary Outcome Measures

Full Information

NCT ID

NCT03362281

First Posted

November 28, 2017

Last Updated

December 4, 2017

Sponsor

Livzon Pharmaceutical Group Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03362281

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Livzon Pharmaceutical Group Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhage, Proton Pump Inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

540 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ilaprazole

Arm Type

Experimental

Arm Title

omeprazole

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Ilaprazole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ilaprazole tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

amoxicillin and clarithromycin

Intervention Description

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

Primary Outcome Measure Information:

Title

the rate of hemostasis

Description

the hemostasis rate checked by endoscopy within 72 hours

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: were 18-70 years of age, male or female. had symptoms of hematemesis, hematochezia, melena within 24 hours and clinically diagnosed as peptic ulcer bleeding. had endoscopically diagnosed gastric or duodenal ulcer bleeding and 3mm ≤ ulcer diameter ≤ 15mm. underwent local hemostasis according to "Acute non-variceal upper gastrointestinal bleeding guidelines (2009, Hangzhou)" Forrest grading; multiple ulcers was judged by the higher level. voluntarily sign informed consent Exclusion Criteria: had hemorrhagic shock ( systolic blood pressure<90mmHg) or require surgery. were non-ulcer bleeding and gastric ulcer biopsy proved malignant. had gastrectomy and gastrointestinal anastomosis. were suffering from serious heart, liver, brain, lung, kidney and other serious diseases. had coagulation disorders (laboratory tests showed that platelets <80 × 109 / L, PT abnormal and exceed the normal control for 3 seconds, APTT than the normal control for 10 seconds). had hypersensitivity or idiosyncratic reaction to ilaprazole, omeprazole, esomeprazole or any other benzimidazole. had positive result of urine pregnancy test. used the same kind of drugs within 48 hours before entering the group. need to continue the combination of the following drugs that have an effect on treatment during the study: NSAIDs, corticosteroids, heparin, warfarin and vitamin K, platelet antagonists or other hemostatic agents. participated in a clinical trial with an investigational drug or device within the past three months. had alcoholic intemperance, drug addiction or other factors that researchers think it unfit for drug clinical trials.

12. IPD Sharing Statement

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

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