Study identifier:D961UC00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Refractory Reflux Esophagitis
Phase 3
No
Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
All
1398
Interventional
20 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2014 by AstraZeneca
AstraZeneca
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This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification
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
Location
Location
Hitachi-shi, Japan
Location
Kawasaki-shi, Japan
Location
Abiko-shi, Japan
Location
Shinjuku-ku, Japan
Location
Saga-shi, Japan
Location
Shibuya-ku, Japan
Location
Fukuoka-shi, Japan
Location
Hirakata-shi, Japan
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 |
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