High dose Esomeprazole Na for prevention of rebleeding after successful endoscopic therapy of a bleeding peptic ulcer
Study identifier:D961DC00007
ClinicalTrials.gov identifier:NCT01757275
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding
Medical condition
bleeding peptic ulcer
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole Na, Cimetidine, Esomeprazole Mg
Sex
All
Actual Enrollment
239
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Feb 2013
Primary Completion Date: 01 Dec 2014
Study Completion Date: 01 Dec 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Feb 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Esomeprazole | Drug: Esomeprazole Na Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous Other Name: Nexium Drug: Esomeprazole Mg 40 mg tablet once daily for 27 days Other Name: Nexium |
| Active Comparator: Cimetidine | Drug: Cimetidine Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours |
Contacts
Investigators
Principal Investigator
Tore Lind
AstraZeneca Molndal, Sweden
