Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Recruitment status was Recruiting
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Purpose
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 |
|---|---|---|
|
Nonvariceal Upper Gastrointestinal Bleeding |
Drug: Intravenous Omeprazole Drug: Oral Rabeprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Comparison of Oral Rabeprazole vs. Intravenous Omeprazole in the Treatment of Patients With Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding |
- 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. [ Time Frame: one year later ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: Intravenous Omeprazole
100 cases of Intravenous Omeprazole
|
Drug: Intravenous Omeprazole
Intravenous Omeprazole 1amp qd (every day)
Other Name: iv losec
|
|
Experimental: Oral Rabeprazole
100 cases of oral rabeprazole
|
Drug: Oral Rabeprazole
Oral Rabeprazole 1 bid
Other Name: pariet
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- moderate to mild upper gastrointestinal peptic ulcer bleeding
Exclusion Criteria:
- shock
- liver cirrhosis
- uremia
- severe UGI bleeding
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chien-Yu Lu, Kaohsiung Medicial University Hospital |
| ClinicalTrials.gov Identifier: | NCT00861640 History of Changes |
| Other Study ID Numbers: | KMUH-IRB-970338 |
| Study First Received: | March 11, 2009 |
| Last Updated: | July 14, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
|
rabeprazole omeprazole upper gastrointestinal bleeding |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Omeprazole Rabeprazole |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013