Conditions: Refractory Reflux Esophagitis
Keywords: Refractory Reflux Esophagitis, Japanese, Nexium, twice daily, oral administration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1398
Healthy volunteers: no

Brief summary:
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

Detailed description:
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

Arms:
arm 1: Double-blinded arm 2: Double-blinded

Interventions: intervention 1: Esomeprazole (D961H) twice daily intervention 2: Esomeprazole (D961H) once daily
Intervention descriptions: intervention 1: One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening intervention 2: 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

Protocol document: