A Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Once Daily Oral Administration With Omeprazole 10 mg and D961H 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis.
Phase 3
- Conditions
- Reflux Esophagitis
- Registration Number
- JPRN-jRCT2080220625
- 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
-Patients with healed Reflux Esophagitis verified by EGD(Esophagogastroduodenoscopy) in the preceding study (D961HC00002)
-Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI
Exclusion Criteria
-Gastric or duodenal ulcer verified by EGD 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 recurrence of Reflux Esophagitis. [ Time Frame: throughout the treatment period ] [ Designated as safety issue: No ]<br>Los Angeles classification
- Secondary Outcome Measures
Name Time Method Presence/absence of recurrence of Reflux Esophagitis. [ Time Frame: at Week 4 or before and Week 12 or before ] [ Designated as safety issue: No ]<br>Los Angeles classification