Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519519
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2007-08-21
Brief Title:
Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers
Status:
COMPLETED
Status Verified Date:
2017-02
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:
Bleeding peptic ulcers are one of the major causes of morbidity and mortality for hospital emergency admissionsThe initial treatment is endoscopic therapy followed by intravenous omeprazole However the optimal dosage of omeprazole is not known We conducted this study to find out the optimal dosage in such clinical scenario
Detailed Description:
Introduction
Peptic ulcer bleeding PUB is a common and life threatening condition Intravenous infusion of high dose omeprazole 80mg as bolus followed by 8 mghr for 72 hours ie 652 mg72 hrs after endoscopic therapy resulted in greater reductions of re-bleeding than did placebo Thus the above regime became our departmental protocol However there is some evidence that both high dose and a regular dose of omeprazole 40mg once a day followed by a saline infusion ie 120mg72 hrs would be equally effective We calculated that high dose regimen is about S 500 more expensive The aim of our study is to determine the equivalence of both regimes in preventing re-bleeding rate primary end-point surgery and mortality in PUB patients
Study design This is a single institution prospective randomized double-blind study All patient with PUB Forrest classification I IIa and IIb spurting or oozing bleeding visible vessels and clot had endoscopic treatments adrenaline injection andor heater probe After successful endoscopic hemostasis patients are randomized to receive a high or regular dose of omeprazole infusion After 72 hours both groups of patients are given oral omeprazole 40mg daily for 4 weeks All patients are evaluated at the clinic at the end of 4 weeks The primary end-point is rebleeding Other secondary endpoints measured are surgery duration of hospital stay and death
Peptic ulcer bleeding PUB is a common and life threatening condition Intravenous infusion of high dose omeprazole 80mg as bolus followed by 8 mghr for 72 hours ie 652 mg72 hrs after endoscopic therapy resulted in greater reductions of re-bleeding than did placebo Thus the above regime became our departmental protocol However there is some evidence that both high dose and a regular dose of omeprazole 40mg once a day followed by a saline infusion ie 120mg72 hrs would be equally effective We calculated that high dose regimen is about S 500 more expensive The aim of our study is to determine the equivalence of both regimes in preventing re-bleeding rate primary end-point surgery and mortality in PUB patients
Study design This is a single institution prospective randomized double-blind study All patient with PUB Forrest classification I IIa and IIb spurting or oozing bleeding visible vessels and clot had endoscopic treatments adrenaline injection andor heater probe After successful endoscopic hemostasis patients are randomized to receive a high or regular dose of omeprazole infusion After 72 hours both groups of patients are given oral omeprazole 40mg daily for 4 weeks All patients are evaluated at the clinic at the end of 4 weeks The primary end-point is rebleeding Other secondary endpoints measured are surgery duration of hospital stay and death
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