Reflux esophagitis Phase III study (Maintenance treatment)
Study identifier:D961HC00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of esomeprazole 20 mg once daily oral administration with omeprazole 10 mg and esomeprazole 10 mg once daily oral administration in maintenance treatment in patients with healed reflux esophagitis
Medical condition
reflux esophagitis
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole, Omeprazole
Sex
All
Actual Enrollment
540
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Jan 2008
Primary Completion Date: -
Study Completion Date: 01 May 2009
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
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 |
|---|---|
| Experimental: 1 Esomeprazole and Omeprazole | Drug: Esomeprazole 10mg once daily oral administration Other Name: Nexium Drug: Omeprazole 10mg once daily oral administration Other Name: Prilosec |
| Experimental: 2 Esomeprazole | Drug: Esomeprazole 20mg once daily oral administration Other Name: Nexium |
Contacts
Investigators
Principal Investigator
Maotsugu Oyama
AstraZeneca
