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Sponsors and Collaborators: |
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Medical University |
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Information provided by: | Kaohsiung Medical University Chung-Ho Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00861640 |
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.
Condition | Intervention | Phase |
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Nonvariceal Upper Gastrointestinal Bleeding |
Drug: Intravenous Omeprazole Drug: Oral Rabeprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Comparison of Oral Rabeprazole vs. Intravenous Omeprazole in the Treatment of Patients With Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding |
Estimated Enrollment: | 200 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intravenous Omeprazole: Experimental
100 cases of Intravenous Omeprazole
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Drug: Intravenous Omeprazole
Intravenous Omeprazole 1amp qd (every day)
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Oral Rabeprazole: Experimental
100 cases of oral rabeprazole
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Drug: Oral Rabeprazole
Oral Rabeprazole 1 bid
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chien-Yu Lu, MD | 886-7-3121101 ext 7451 | dr820188@pchome.com.tw |
Taiwan | |
Kaohsiung Medical University Hospital | Recruiting |
Kaohsiung, Taiwan, 807 | |
Contact: Chien-Yu Lu, MD 886-7-3121101 ext 7451 dr820188@pchome.com.tw | |
Principal Investigator: Chien-Yu Lu, MD |
Principal Investigator: | Chien-Yu Lu, MD | Kaohsiung Medical University |
Responsible Party: | Kaohsiung Medicial University Hospital ( Chien-Yu Lu ) |
Study ID Numbers: | KMUH-IRB-970338 |
Study First Received: | March 11, 2009 |
Last Updated: | March 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00861640 History of Changes |
Health Authority: | Taiwan: Department of Health |
rabeprazole omeprazole upper gastrointestinal bleeding |
Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage |
Omeprazole Hemorrhage Rabeprazole |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Hemorrhage Gastrointestinal Agents Omeprazole Enzyme Inhibitors Hemorrhage |
Pharmacologic Actions Digestive System Diseases Pathologic Processes Therapeutic Uses Anti-Ulcer Agents Rabeprazole |