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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.

Tracking Information
First Submitted Date  ICMJE November 28, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 6, 2017
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
the rate of hemostasis [ Time Frame: 72 hours ]
the hemostasis rate checked by endoscopy within 72 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients
Official Title  ICMJE Efficacy and Safety of Intravenous IIaprazole for Peptic Ulcer Bleeding: A Randomized, Double-Blind, Omeprazole-Controlled, Multicenter, and Phase 3 Trail in China
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peptic Ulcer Hemorrhage
Intervention  ICMJE
  • Drug: Ilaprazole
    10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling.
  • 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
Study Arms  ICMJE
  • Experimental: Ilaprazole
    Interventions:
    • Drug: Ilaprazole
    • Drug: Ilaprazole tablet
    • Drug: amoxicillin and clarithromycin
  • Active Comparator: omeprazole
    Interventions:
    • Drug: Omeprazole
    • Drug: Ilaprazole tablet
    • Drug: amoxicillin and clarithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2017)
540
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362281
Other Study ID Numbers  ICMJE Livzon-IYI-Ⅲ
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Livzon Pharmaceutical Group Inc.
Study Sponsor  ICMJE Livzon Pharmaceutical Group Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Livzon Pharmaceutical Group Inc.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP