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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Livzon Pharmaceutical Group Inc.
• Treatments: Amoxicillin; Clarithromycin; Omeprazole

Criteria

Inclusion Criteria:

1. were 18-70 years of age, male or female.

2. had symptoms of hematemesis, hematochezia, melena within 24 hours and clinically diagnosed as peptic ulcer bleeding.

3. had endoscopically diagnosed gastric or duodenal ulcer bleeding and 3mm ≤ ulcer diameter ≤ 15mm.

4. underwent local hemostasis according to "Acute non-variceal upper gastrointestinal bleeding guidelines (2009, Hangzhou)" Forrest grading; multiple ulcers was judged by the higher level.

5. voluntarily sign informed consent

Exclusion Criteria:

1. had hemorrhagic shock ( systolic blood pressure<90mmHg) or require surgery.

2. were non-ulcer bleeding and gastric ulcer biopsy proved malignant.

3. had gastrectomy and gastrointestinal anastomosis.

4. were suffering from serious heart, liver, brain, lung, kidney and other serious diseases.

5. 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).

6. had hypersensitivity or idiosyncratic reaction to ilaprazole, omeprazole, esomeprazole or any other benzimidazole.

7. had positive result of urine pregnancy test.

8. used the same kind of drugs within 48 hours before entering the group.

9. 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.

10. participated in a clinical trial with an investigational drug or device within the past three months.

11. had alcoholic intemperance, drug addiction or other factors that researchers think it unfit for drug clinical trials.