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

NCT00861640 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2009-07-15

No results posted yet for this study

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.

Conditions

  • Nonvariceal Upper Gastrointestinal Bleeding

Interventions

DRUG

Intravenous Omeprazole

Intravenous Omeprazole 1amp qd (every day)

DRUG

Oral Rabeprazole

Oral Rabeprazole 1 bid

Sponsors & Collaborators

  • Kaohsiung Medical University

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • Chien-Yu Lu, MD · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861640 on ClinicalTrials.gov