A study to prevent rebleeding after initial successful primary endoscopic haemostasis of a bleeding peptic ulcer
Study identifier:D961DC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, double-blind, parallel-group, placebo controlled study of esomeprazole i.v. (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour) administered for 72 hours to assess prevention of rebleeding in subjects that have undergone successful primary endoscopic haemostasis of a bleeding peptic ulcer – the PUB study.
Medical condition
Gastrointestinal Hemorrhage
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole
Sex
All
Actual Enrollment
1312
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Oct 2005
Primary Completion Date: 01 Dec 2007
Study Completion Date: 01 Dec 2007
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
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Contacts
Investigators
Principal Investigator
AstraZeneca Nexium Medical Sciences Director
AstraZeneca
