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