Overview

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 ยท 2.Unstable vital signs