Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients
Condition: Peptic Ulcer Hemorrhage
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Ilaprazole; Omeprazole; Ilaprazole tablet; amoxicillin and clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling.; 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min.; Since 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day; The Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks
Intervention MeSH terms: Amoxicillin; Clarithromycin; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peptic ulcer hemorrhage; Proton Pump Inhibitor