High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
Condition: Bleeding Peptic Ulcer
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Intervention: Esomeprazole Na; Cimetidine; Esomeprazole Mg
Intervention description: Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous; Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours; 40 mg tablet once daily for 27 days
Intervention MeSH terms: Esomeprazole; Cimetidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: peptic ulcer bleeding; prevention of rebleeding; successful endoscopic haemostatic therapy

Summary:

      To describe the rate of clinically significant rebleeding during 72 hours continuous i.v.
      infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic
      haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures.

          -  Female or male aged =18 years and =70 years.

          -  Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such
             signs within the last 24 hours as judged by the investigator.

          -  One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm
             in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the
             source of bleeding should be provided.

          -  Successful haemostasis (which is considered to have been established if bleeding has
             stopped and, if applicable, formerly bleeding vessels are flattened or cavitated)
             achieved by endoscopic treatment and confirmed by site staff.

        Exclusion Criteria:

          -  Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the
             investigator.

          -  Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux
             esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon,
             small bowel, or ulcer distal to the stom in Billroth-resected patients.

          -  Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2
             (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.

          -  Planned treatment with: warfarin (including other vitamin K antagonists), cisapride,
             phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,
             theophylline, lidocaine, nifedipine.

          -  Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned
             during the course of the study.