Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247130
Status:
WITHDRAWN
Last Update Posted:
2015-04-03
First Post:
2005-10-28
Brief Title:
Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer
Sponsor:
Keio University
Organization:
Keio University
Study Overview
Official Title:
A Prospective Randomized Trial Comparing the Effect of Intravenous Omeprazole to That of Intravenous Ranitidine on the Maintenance of Hemostasis After Successful Endoscopic Treatment of Bleeding Peptic Ulcer
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Superiority of iv omeprazole to ranitidine has already been proven by others
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will compare the hemostasis-maintaining effects of intravenous omeprazole and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone endoscopic hemostasis to establish which anti-secretory medication prior to the start of oral alimentation is effective in preventing re-hemorrhage after hemostasis
Detailed Description:
Gastrointestinal hemorrhage is a relatively common condition with the source of the bleeding being most commonly from the upper gastrointestinal tract especially from gastric and duodenal ulcers It often requires emergency treatment First the site of bleeding is determined If an exposed blood vessel is found in the hemorrhagic lesion or in the case of oozing or projectile hemorrhage endoscopic hemostasis is performed on the lesion After hemostasis is achieved prevention of re-bleeding is important usually an antacid or similar medication is administered and the course is monitored under fasting conditionsSuppression of gastric acid secretion is necessary to raise gastric pH levels and maintain normal blood coagulation and to promote healing of hemorrhagic lesions In Japan intravenous preparations of H2 receptor antagonists and proton pump inhibitors have been commonly usedIn foreign countries drug therapy for patients with upper gastrointestinal hemorrhage emphasizes the maintenance of normal blood coagulation High doses of these drugs have been established to constantly maintain a pH of 7 in the stomach Daneshmend TK et al BMJ 1992 304143-147 Labentz J et al Gut 1997 4036-41 Hasselgren G et al Scand J Gastroenterol 1997 32328-333 Schaffalitzky de Muckadell OB et al Scand J Gastroenterol 1997 32320-327 Sung JJY et al Ann Intern Med 2003 139237-243 In a clinical study proton pump inhibitors were superior to H2 receptor antagonists in terms of clinical efficacy Labentz J et al Gut 1997 4036-41 In Japan emphasis is placed on promoting healing of lesions since endoscopic hemostasis is a fairly common practice doses have been established at levels similar to therapeutic doses for peptic ulcers It cannot be said however that superiority of intravenous proton pump inhibitors over H2 receptor antagonists has been established at such doses This can possibly be attributed to fact that in previous studies the study populations were not homogenous in terms of severity for example patients requiring endoscopic hemostasis and those that did not were both includedAgainst this background this study will compare the hemostasis-maintaining effects of intravenous omeprazole and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone endoscopic hemostasis to establish which anti-secretory medication prior to the start of oral alimentation is effective in preventing re-hemorrhage after hemostasis
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