Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastrointestinal Hemorrhage
Intervention: Esomeprazole IV (Drug); Omeprazole IV (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Tore Lind, MD, Study Director, Affiliation: AstraZeneca
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
Clinical Details
Official title: A Randomised, Double-Blind, Double-Dummy, Active-Controlled, Multicenter Study to Assess the Efficacy and Safety of Esomeprazole or Omeprazole for 5 Days in Subjects With Acute Non-Variceal Upper Gastrointestinal Bleeding
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
Secondary outcome: Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatmentTime to absence of clinically significant upper GI bleeding
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Shanghai, China
Research Site, Beijing, China
Research Site, Tianjin, China
Research site, Fuzhou, Fujian, China
Research Site, Guangzhou, Guangdong, China
Research Site, Wuhan, Hubei, China
Research Site, Xi'an, Shanxi, China
Additional Information
Starting date: August 2006
Last updated: February 4, 2008
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