Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole; Omeprazole

Criteria

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