Comparative Efficacy & Safety Study of esomeprazole Versus Placebo for the Prevention of gastric and duodenal ulcers with NSAID
Study identifier:D961HC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of esomeprazole(20 mg once daily) Versus Placebo 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, Placebo
Sex
All
Actual Enrollment
343
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Aug 2007
Primary Completion Date: -
Study Completion Date: 01 Feb 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 May 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 Placebo | Drug: Placebo once daily oral |
| Experimental: 2 Esomeprazole 20 mg | Drug: Esomeprazole 20mg once daily oral Other Name: Nexium |
Contacts
Investigators
Principal Investigator
Naotsugu Oyama
AstraZeneca Japan
