Phase 3 N=311 Randomized Double-blind Prevention

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

Stress Ulcer Prophylaxis

Bottom Line

View on ClinicalTrials.gov: NCT02157376 ↗

Enrolled (actual)

311

Serious AEs

8.7%

Results posted

Jan 2017

Primary outcome: Primary: The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase — 2.7; 4.6 % of participants — p=0.393

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Esomeprazole (Drug); Cimetidine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Feb 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02157376). 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.