Status:
COMPLETED
Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients
Lead Sponsor:
Livzon Pharmaceutical Group Inc.
Conditions:
Peptic Ulcer Hemorrhage
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 diagno...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT03362281
Start Date
October 1 2014
End Date
April 1 2015
Last Update
December 6 2017
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