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.