Long Term Study to investigate the Efficacy & Safety of D961H (Esomeprazole) for the prevention of NSAIDs-induced ulcer
Study identifier:D961HC00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg once daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated with Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Medical condition
Gastric Ulcer, Rheumatoid Arthritis, Osteoarthritis
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole 20 mg
Sex
All
Actual Enrollment
395
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: 01 Sept 2009
Study Completion Date: 01 Sept 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Verification:
Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily | Drug: Esomeprazole 20 mg Esomeprazole 20 mg once daily |
Contacts
Investigators
Principal Investigator
Naotsugu Oyama
AstraZeneca
