Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding

Phase 4

• Conditions: Nonvariceal Upper Gastrointestinal Bleeding
• Interventions: Drug: Intravenous Omeprazole; Drug: Oral Rabeprazole

• Registration Number: NCT00861640
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Detailed Description

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.

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. The expected numbers of intravenous and oral PPI were 100 respectively.

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.

At the end of this study, we will be able to determine whether patients treated with oral rabeprazole and iv pantoprazole have similar re-bleeding or complication rates and hospitalization days.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15
• Primary Completion: 2010-03
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• moderate to mild upper gastrointestinal peptic ulcer bleeding

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Exclusion Criteria

• shock
• liver cirrhosis
• uremia
• severe UGI bleeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Omeprazole	Intravenous Omeprazole	100 cases of Intravenous Omeprazole
Oral Rabeprazole	Oral Rabeprazole	100 cases of oral rabeprazole

Primary Outcome Measures

Name	Time	Method
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.	one year later

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan