Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00861640
Status:
UNKNOWN
Last Update Posted:
2009-07-15
First Post:
2009-03-11
Brief Title:
Comparison of Oral Rabeprazole vs iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
The Comparison of Oral Rabeprazole vs Intravenous Omeprazole in the Treatment of Patients With Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Its 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
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 Its 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None