Overview

Reflux Esophagitis Phase III Study (Maintenance Treatment)

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Esomeprazole
Omeprazole
Criteria
Inclusion Criteria:

- Patients with healed Reflux Esophagitis verified by EGD 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.