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

NCT03362281 | Completed Phase 3

• 1 other identifier: Livzon-IYI-Ⅲ
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhage; Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

• the rate of hemostasis

  the hemostasis rate checked by endoscopy within 72 hours

  72 hours

Study Arms (2)

Ilaprazole

EXPERIMENTAL

Drug: Ilaprazole; Drug: Ilaprazole tablet; Drug: amoxicillin and clarithromycin

omeprazole

ACTIVE COMPARATOR

Drug: Omeprazole; Drug: Ilaprazole tablet; Drug: amoxicillin and clarithromycin

Interventions

Ilaprazole DRUG

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

Ilaprazole

Omeprazole DRUG

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

omeprazole

Ilaprazole tablet DRUG

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

Ilaprazole; omeprazole

amoxicillin and clarithromycin DRUG

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

Ilaprazole; omeprazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

ilaprazole; Omeprazole; Amoxicillin; Clarithromycin

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 5, 2017
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 6, 2017

Record last verified: 2017-11