Prevention of Gastric Ulcers
Study identifier:SH-NEN-0013
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Comparative Efficacy and Safety Study of Nexium (esomeprazole magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) versus Placebo for the prevention of Gastric Ulcers Associated with Daily NSAID Use in Patients at Risk
Medical condition
NSAID associated Gastric Ulcers
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole, Placebo
Sex
All
Actual Enrollment
504
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Mar 2001
Primary Completion Date: 01 Dec 2002
Study Completion Date: 01 Dec 2002
Study design
Allocation: Randomized
Endpoint Classification: Safety/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
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 20mg oral daily | Drug: Esomeprazole 20mg oral daily Other Name: Nexium |
| Experimental: 2 40mg oral daily | Drug: Esomeprazole 40mg oral daily Other Name: Nexium |
| Placebo Comparator: 3 | - |
Contacts
Investigators
Principal Investigator
Professor Chris Hawkey
Queens Medical Centre
