Ulcer prevention II
Study identifier:SH-NEN-0014
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Comparative Efficacy and Safety of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric and Duodenal 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
800
Study type
Interventional
Age
18 Years - 60 Years
Date
Study Start Date: 01 Feb 2001
Primary Completion Date: 01 Mar 2003
Study Completion Date: 01 Mar 2003
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 capsule once daily | Drug: Esomeprazole 20mg oral capsule daily Other Name: Nexium |
| Experimental: 2 40mg capsule daily | Drug: Esomeprazole 40mg oral capsule daily Other Name: Nexium |
| Placebo Comparator: 3 | - |
Contacts
Investigators
Principal Investigator
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
