Phase 3
Completed N=311
Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
Stress Ulcer Prophylaxis
Source: ClinicalTrials.gov NCT02157376 ↗
Enrolled (actual)
311
Serious AEs
8.7%
Results posted
Jan 2017
Primary outcomePrimary: The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase — 2.7; 4.6 % of participants — p=0.393
◆ Published Evidence
Emerging
18citations · ~2 / year
Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine.
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.
Linked Publications
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Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase |
2.7; 4.6 | 0.393 |
| SECONDARY Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase |
0.109; 0.105 | — |
Eligibility Criteria
Inclusion Criteria
- Critically ill patients
- Requirement for mechanical ventilation
- At least one major risk factor for stress ulcer related bleeding
Exclusion Criteria
- History of gastric or oesophageal surgery
- Evidence of active GI bleeding
- Advanced renal disease
- Treatment with any Proton Pump Inhibitors
Data sourced from ClinicalTrials.gov (NCT02157376) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.