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

Nonvariceal Upper Gastrointestinal Bleeding research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - moderate to mild upper gastrointestinal peptic ulcer bleeding Exclusion Criteria: - shock - liver cirrhosis - uremia - severe UGI bleeding

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nonvariceal Upper Gastrointestinal Bleeding

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Intravenous OmeprazoleIntravenous Omeprazole 1amp qd (every day)

Drug:Oral RabeprazoleOral Rabeprazole 1 bid

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Intravenous Omeprazole100 cases of Intravenous Omeprazole

Oral Rabeprazole100 cases of oral rabeprazole

Study Status

Unknown status

Start Date: March 2009

Completed Date: April 2010

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Chien-Yu Lu, MD

Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborator: Kaohsiung Medical University

More information:https://clinicaltrials.gov/show/NCT00861640

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