Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients — SUP  

Stress Ulcer Prophylaxis Clinical Trial

Official title: Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stress Ulcer Prophylaxis
• Ulcer

• NCT number: NCT02157376
• Study type: Interventional
• Source: AstraZeneca
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 2014
• Completion date: February 2016