Status:
COMPLETED
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
Lead Sponsor:
AstraZeneca
Conditions:
Gastrointestinal Hemorrhage
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00402259
Start Date
August 1 2006
End Date
October 1 2007
Last Update
March 12 2009
Active Locations (7)
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1
Research site
Fuzhou, Fujian, China
2
Research Site
Guangzhou, Guangdong, China
3
Research Site
Wuhan, Hubei, China
4
Research Site
Xi’an, Shanxi, China