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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362281
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: Ilaprazole Drug: Omeprazole Drug: Ilaprazole tablet Drug: amoxicillin and clarithromycin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ilaprazole Drug: Ilaprazole
10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling.

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

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

Active Comparator: omeprazole Drug: Omeprazole
40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min.

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

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




Primary Outcome Measures :
  1. the rate of hemostasis [ Time Frame: 72 hours ]
    the hemostasis rate checked by endoscopy within 72 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT03362281    
Other Study ID Numbers: Livzon-IYI-Ⅲ
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Livzon Pharmaceutical Group Inc.:
Peptic ulcer hemorrhage
Proton Pump Inhibitor
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Amoxicillin
Clarithromycin
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors