At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 239 enrolled
Drug / intervention
Esomeprazole Na +2 moredrug
Likely dose
Esomeprazole Na 80mgfrom 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.
A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding
In Brief
A Phase 3 clinical trial evaluating Esomeprazole Na, Cimetidine, and 1 other intervention for Bleeding Peptic Ulcer. Completed, enrolled 239 participants across 12 sites.
Detailed Summary
To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding Peptic Ulcer
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartFeb 2013
Primary CompletionDec 2014
TodayJul 2026
First PostedDec 28, 2012
Enrollment StartFeb 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.5 years ago
Interventions
Esomeprazole Nadrug
Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous
Cimetidinedrug
Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours
Esomeprazole Mgdrug
40 mg tablet once daily for 27 days