NCT02157376

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stress Ulcer Prophylaxis

Interventions

Type	Name	Description
DRUG	Esomeprazole	iv esomeprazole 30 min intermittent infusions given for maximum 14 days
DRUG	Cimetidine	iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-06-06
• Last updated: 2017-03-10
• Results posted: 2017-01-23

Locations

15 sites across 1 country: China