Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Chinese University of Hong Kong |
---|---|
Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00164931 |
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.
Condition | Intervention | Phase |
---|---|---|
Peptic Ulcer Hemorrhage |
Drug: Intravenous omeprazole infusion Procedure: Scheduled second endoscopy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | October 2003 |
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 13.8% 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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Philip WY Chiu, MBChB, FRCSEd | 26322627 | pwychiu@netvigator.com |
Contact: Henry KM Joeng, MBBS | 35134000 | henryjoeng@misdc.org |
China | |
Department of Surgery, United Christian Hospital | Recruiting |
Hong Kong, China | |
Contact: Philip WY Chiu, MBChB, FRCSEd 26322627 pwychiu@netvigator.com | |
Contact: Henry KM Joeng, MBBS 35134000 henryjoeng@misdc.org | |
Sub-Investigator: Catherine LY Choi, MBBS | |
Sub-Investigator: Kwok Hung Kwong, MBChB, FRCSEd | |
Sub-Investigator: Siu Ho Lam, MBBS, FRCSEd |
Principal Investigator: | Philip WY Chiu, MBChB, FRCSEd | Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong |
Principal Investigator: | Henry KM Joeng, MBBS | Department of Surgery, United Christian Hospital, Hong Kong |
Study ID Numbers: | UCHCE03-43-SURG5 |
Study First Received: | September 11, 2005 |
Last Updated: | November 16, 2005 |
ClinicalTrials.gov Identifier: | NCT00164931 History of Changes |
Health Authority: | Hong Kong: Department of Health |
Peptic ulcer hemorrhage Omeprazole Scheduled second endoscopy |
Stomach Diseases Digestive System Diseases Gastrointestinal Diseases Ulcer Peptic Ulcer Hemorrhage Gastrointestinal Hemorrhage |
Omeprazole Intestinal Diseases Hemorrhage Duodenal Diseases Peptic Ulcer |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Ulcer Gastrointestinal Agents Gastrointestinal Hemorrhage Omeprazole Enzyme Inhibitors Hemorrhage Intestinal Diseases |
Pharmacologic Actions Pathologic Processes Digestive System Diseases Stomach Diseases Therapeutic Uses Peptic Ulcer Hemorrhage Anti-Ulcer Agents Peptic Ulcer Duodenal Diseases |