Compare D961H 20 mg bid and 20 mg qd in patients with refractory reflux esophagitis (inflammation of lower esophagus)
Study identifier:D961UC00002
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 D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis
Medical condition
Refractory Reflux Esophagitis
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
Sex
All
Actual Enrollment
1398
Study type
Interventional
Age
20 Years - 150 Years
Date
Study Start Date: 01 Aug 2012
Primary Completion Date: 01 May 2014
Study Completion Date: 01 May 2014
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: D961H 20mg twice daily Double-blinded | Drug: Esomeprazole (D961H) twice daily One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening |
| Active Comparator: D961H 20mg once daily Double-blinded | Drug: Esomeprazole
(D961H) once daily One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening |
Contacts
Investigators
Principal Investigator
Tore Lind
AstraZeneca, Moelndal, Sweden
