drugset / Trial / NCT00634114

Reflux Esophagitis Phase III Study (Maintenance Treatment)

NCT00634114

Phase 3 Completed 540 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-01
Primary completion
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 10 mg Oral
Subject Esomeprazole Small molecule 20 mg Oral
Subject Omeprazole Other / unclassified 10 mg Oral

Indications