Efficacy and safety study of Esomeprazole vs Omeprazole to treat acute non-variceal upper gastrointestinal bleeding

Study identifier:D961DL00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Gastrointestinal Hemorrhage

Phase

Phase 3

Healthy volunteers

No

Study drug

Esomeprazole IV, Omeprazole IV

Sex

All

Actual Enrollment

440

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Aug 2006
Primary Completion Date: -
Study Completion Date: 01 Oct 2007

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria