Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
Phase 3
Completed
- Conditions
- Gastrointestinal Hemorrhage
- Registration Number
- NCT00402259
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
- Male or female aged 18-65 years.
- GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
- One endoscopically confirmed bleeding peptic ulcer or erosive gastritis
Exclusion Criteria
- GI bleeding caused by Esophageal varices
- Mallory Weiss syndrome
- Zollinger-Ellison syndrome
- Suspicion of gastric malignancy at baseline endoscopy
- Post-Billroth-resection
- Unknown source of GI bleeding · 2.Unstable vital signs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
- Secondary Outcome Measures
Name Time Method Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment Time to absence of clinically significant upper GI bleeding
Trial Locations
- Locations (2)
Research site
🇨🇳Fuzhou, Fujian, China
Research Site
🇨🇳Tianjin, China
Research site🇨🇳Fuzhou, Fujian, China