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
Study identifier:SH-NEN-0006
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 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
Medical condition
NSAID associated Gastric Ulcers
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole, Ranitidine
Sex
Unmapped
Actual Enrollment
400
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Feb 2001
Primary Completion Date: 01 Oct 2003
Study Completion Date: 01 Oct 2003
Study design
Allocation: None
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
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 20mg Oral tablet daily | Drug: Esomeprazole 20mg Oral tablet once daily Other Name: Nexium |
| Experimental: 2 40mg oral tablet daily | Drug: Esomeprazole 40mg oral tablet once 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
