CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
omeprazole +1 moredrug
Likely dose
omeprazole 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02536989
NCT02536989Phase 4Completed

Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot

Far Eastern Memorial Hospital·interventional·Posted Sep 1, 2015·Updated Feb 8, 2016

In Brief

A Phase 4 clinical trial evaluating omeprazole for Peptic Ulcer and Hemorrhage. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2015
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.8 years ago

Interventions

omeprazoledrug

receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days

omeprazoledrug

receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days