Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164931
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-11
Brief Title:
A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
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:
A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy
Detailed Description:
We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding We found that the rate of recurrent bleeding was significantly reduced from 138 to 5 with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis
When we look at the studies in the literature employing proton pump inhibitors PPI infusion after primary endoscopic therapy we found that there was also a significant reduction in the rate of rebleeding the number of operation performed and the transfusion requirement
Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding
We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers
When we look at the studies in the literature employing proton pump inhibitors PPI infusion after primary endoscopic therapy we found that there was also a significant reduction in the rate of rebleeding the number of operation performed and the transfusion requirement
Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding
We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers
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