A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) versus Ranitidine 150mg bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is continued in subjects in the US only
Study identifier:SH-NEN-0005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
-
Medical condition
NSAID associated Gastric Ulcers
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole, Ranitidine
Sex
All
Actual Enrollment
400
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Feb 2001
Primary Completion Date: -
Study Completion Date: 01 Mar 2003
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
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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 20mg Oral tablet daily | Drug: Esomeprazole 20mg oral daily Other Name: Nexium |
| Experimental: 2 40mg Oral tablet daily | Drug: Esomeprazole 40mg oral tablet daily Other Name: Nexium |
| Active Comparator: 3 150mg oral twice daily | Drug: Ranitidine 150mg oral twice daily Other Name: Zantac |
Contacts
Investigators
Principal Investigator
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
