Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Primary Purpose
Nonvariceal Upper Gastrointestinal Bleeding
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Intravenous Omeprazole
Oral Rabeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Nonvariceal Upper Gastrointestinal Bleeding focused on measuring rabeprazole, omeprazole, upper gastrointestinal bleeding
Eligibility Criteria
Inclusion Criteria:
- moderate to mild upper gastrointestinal peptic ulcer bleeding
Exclusion Criteria:
- shock
- liver cirrhosis
- uremia
- severe UGI bleeding
Sites / Locations
- Kaohsiung Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intravenous Omeprazole
Oral Rabeprazole
Arm Description
100 cases of Intravenous Omeprazole
100 cases of oral rabeprazole
Outcomes
Primary Outcome Measures
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 Measures
Full Information
NCT ID
NCT00861640
First Posted
March 11, 2009
Last Updated
July 14, 2009
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00861640
Brief Title
Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Official Title
The Comparison of Oral Rabeprazole vs. Intravenous Omeprazole in the Treatment of Patients With Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonvariceal Upper Gastrointestinal Bleeding
Keywords
rabeprazole, omeprazole, upper gastrointestinal bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Omeprazole
Arm Type
Experimental
Arm Description
100 cases of Intravenous Omeprazole
Arm Title
Oral Rabeprazole
Arm Type
Experimental
Arm Description
100 cases of oral rabeprazole
Intervention Type
Drug
Intervention Name(s)
Intravenous Omeprazole
Other Intervention Name(s)
iv losec
Intervention Description
Intravenous Omeprazole 1amp qd (every day)
Intervention Type
Drug
Intervention Name(s)
Oral Rabeprazole
Other Intervention Name(s)
pariet
Intervention Description
Oral Rabeprazole 1 bid
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
moderate to mild upper gastrointestinal peptic ulcer bleeding
Exclusion Criteria:
shock
liver cirrhosis
uremia
severe UGI bleeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Yu Lu, MD
Phone
886-7-3121101
Ext
7451
Email
dr820188@pchome.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Yu Lu, MD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Yu Lu, MD
Phone
886-7-3121101
Ext
7451
Email
dr820188@pchome.com.tw
First Name & Middle Initial & Last Name & Degree
Chien-Yu Lu, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
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