Clinical Trial: Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: November 17, 2006
Date Started: August 2006
Date Completion:
Last Updated: March 11, 2009
Last Verified: March 2009
