IIaprazole 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 2

Summary: 
      The purpose of this study is to compare the efficacy and safety of ilaprazole and omeprazole
      in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically
      diagnosed peptic ulcer bleeding were enrolled in a randomized, 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 and be seen at day 3, 4, 7, 14 and 30. The
      primary endpoint was the hemostasis rate (hemostatic groups with endoscopy check ) and
      re-bleeding rate ( bleeding groups with endoscopy check) within 72 hours. Secondary end
      points include effective rate of hemostasis, mean volume of blood transfusion, the length of
      stay and re-bleeding rate, etc.
    

Detailed description: 
      Patients with endoscopically diagnosed gastric and duodenal ulcer bleeding were randomly
      assigned into two groups, ilaprazole and omeprazole. 120 patients were administrated 10 mg
      ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose
      doubling. Since 4th day, those patients were changed to oral administration. Other 60
      patients were administrated 40 mg omeprazole twice daily (at day 1-3) through intravenous
      infusion within 30min. Since 4th day, those patients were changed to oral administration. The
      efficacy of ilaprazole and omeprazole was evaluated by the primary endpoint including the
      hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate (bleeding
      groups with endoscopy check) within 72 hours and secondary end points including effective
      rate of hemostasis, average blood transfusion, the need to switch to other treatments
      (endoscopic treatment or surgery, etc.), hospital stay and re-bleeding rate at day 7, 14 and
      30. Safety assessments based mainly on the occurrence, frequency, and severity of adverse
      events, which were monitored throughout the duration of the study, and also based on
      comprehensive indexes,including physical examination, electrocardiography, and routine
      laboratory investigations, which were performed at baseline and repeated at the end of the
      treatment period. For all adverse events, where necessary, patients were withdrawn from the
      study.This phase Ⅱ clinical trial was designed to compare the efficacy and safety of
      ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding.
    

Intervention name(s): Ilaprazole; omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Since 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day; 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min,Since 4th day, those patients were changed to take oral omeprazole tablets 20mg each day till 30th day
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment