NCT00634114

Reflux Esophagitis Phase III Study (Maintenance Treatment)

A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Reflux Esophagitis

Interventions

Type	Name	Description
DRUG	Esomeprazole	10mg once daily oral administration
DRUG	Esomeprazole	20mg once daily oral administration
DRUG	Omeprazole	10mg once daily oral administration

Timeline

• Start date: 2008-01-01
• Completion: 2009-05-01
• First posted: 2008-03-12
• Last updated: 2010-06-17
• Results posted: 2010-06-17

Locations

44 sites across 1 country: Japan