Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Status:
Unknown status
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Introduction: Proton pump inhibitor (PPI) is the drug of choice used in patients with
non-variceal upper gastrointestinal tract bleeding (UGIB). Intravenous (IV) PPI is more
commonly used than oral form when overt bleeding occurs. Previous study has revealed that
oral rabeprazole and IV omeprazole achieved similar intragastric pH elevation. It's probable
that oral form and IV PPI provide equal efficacy in treating mild to moderate UGIB patients.
Aim: This study aims to compare the effect of three-day oral rabeprazole and iv omeprazole on
bleeding control in patients with mild to moderate non-variceal UGIB.
Patients and methods: All patients presented with black to tarry stool passage or hematemesis
and visited our ER will be evaluated to recruit into this study. They will receive regular
vital sign monitoring, laboratory study and nasogastric tube insertion with gastric fluid
aspiration. Esophagogastroendoscopy and hemostatic procedure if need will be performed within
12 hours. Those confirmed to have non-variceal UGIB, stable vital signs and agree to
participate into this study will be randomized into two groups receiving either oral
rabeprazole (20mg bid) or iv omeprazole (40mg qd) for three days. The presence of recurrent
bleeding within three days, in-hospital complication and duration of hospital stay will be
recorded and analyzed.
Expected results: At the end of this study, we will be able to determine whether patients
treated with oral rabeprazole and iv omeprazole have similar re-bleeding or complication
rates and hospitalization days.
Phase:
Phase 4
Details
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital