A Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis.
Phase 3
- Conditions
- Reflux Esophagitis
- Registration Number
- JPRN-jRCT2080220624
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Accepts Healthy Volunteers: No
-Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation
Exclusion Criteria
-Gastric or duodenal ulcer verified by EGD(Esophagogastroduodenoscopy) within 12 weeks before randomisation.
-Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence/absence of Reflux Esophagitis[ Time Frame: 8 weeks ] [ Designated as safety issue: No ]<br>Los Angeles classification
- Secondary Outcome Measures
Name Time Method Presence/absence of Reflux Esophagitis[ Time Frame: 4 weeks ] [ Designated as safety issue: No ]<br>Los Angeles classification