At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 enrolled
Drug / intervention
Esomeprazole +1 moredrug
Likely dose
Not stated in 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.
Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study
In Brief
A Phase 3 clinical trial evaluating Esomeprazole and Cimetidine for Stress Ulcer Prophylaxis. Completed, enrolled 343 participants across 15 sites.
Detailed Summary
The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Ulcer Prophylaxis
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJul 2014
Primary CompletionFeb 2016
TodayJul 2026
First PostedJun 6, 2014
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.1 years ago
Interventions
Esomeprazoledrug
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
Cimetidinedrug
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days