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

Primary Purpose

Peptic Ulcer Hemorrhage

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ilaprazole

omeprazole

About this trial

This is an interventional treatment trial for Peptic Ulcer Hemorrhage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

were 18-65 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 (multiple ulcers was judged by the higher Forrest level).
were patients of Forrest Ⅰa-Ⅱb level and had successful endoscopic surgery to stop bleeding (bleeding was cured and the blood vessels were flat or became into the lumen). Ⅱc-Ⅲ grade patients did not receive endoscopic hemostasis.
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 peptic ulcer hemorrhage patients

Measure: The hemostasis rate checked by endoscopy within 72 hours

Secondary Outcome Measures

Full Information

NCT ID

NCT03362268

First Posted

November 28, 2017

Last Updated

December 4, 2017

Sponsor

Livzon Pharmaceutical Group Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03362268

Brief Title

IIaprazole 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 2 Trail in China

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

July 2014 (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 study is to compare the efficacy and safety of ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a randomized, 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 and be seen at day 3, 4, 7, 14 and 30. The primary endpoint was the hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate ( bleeding groups with endoscopy check) within 72 hours. Secondary end points include effective rate of hemostasis, mean volume of blood transfusion, the length of stay and re-bleeding rate, etc.

Detailed Description

Patients with endoscopically diagnosed gastric and duodenal ulcer bleeding were randomly assigned into two groups, ilaprazole and omeprazole. 120 patients were administrated 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Since 4th day, those patients were changed to oral administration. Other 60 patients were administrated 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min. Since 4th day, those patients were changed to oral administration. The efficacy of ilaprazole and omeprazole was evaluated by the primary endpoint including the hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate (bleeding groups with endoscopy check) within 72 hours and secondary end points including effective rate of hemostasis, average blood transfusion, the need to switch to other treatments (endoscopic treatment or surgery, etc.), hospital stay and re-bleeding rate at day 7, 14 and 30. Safety assessments based mainly on the occurrence, frequency, and severity of adverse events, which were monitored throughout the duration of the study, and also based on comprehensive indexes,including physical examination, electrocardiography, and routine laboratory investigations, which were performed at baseline and repeated at the end of the treatment period. For all adverse events, where necessary, patients were withdrawn from the study.This phase Ⅱ clinical trial was designed to compare the efficacy and safety of ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding.

6. Conditions and Keywords

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

Peptic Ulcer Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

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

Intervention Type

Drug

Intervention Name(s)

omeprazole

Intervention Description

40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min,Since 4th day, those patients were changed to take oral omeprazole tablets 20mg each day till 30th day

Primary Outcome Measure Information:

Title

The rate of hemostasis peptic ulcer hemorrhage patients

Description

Measure: 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

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: were 18-65 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 (multiple ulcers was judged by the higher Forrest level). were patients of Forrest Ⅰa-Ⅱb level and had successful endoscopic surgery to stop bleeding (bleeding was cured and the blood vessels were flat or became into the lumen). Ⅱc-Ⅲ grade patients did not receive endoscopic hemostasis. 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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IIaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients

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