CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 540 enrolled
Drug / intervention
Esomeprazole +2 moredrug
Likely dose
Esomeprazole 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00634114
NCT00634114Phase 3Completed

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

AstraZeneca·interventional·Posted Mar 12, 2008·Updated Jun 17, 2010

In Brief

A Phase 3 clinical trial evaluating Esomeprazole and Omeprazole for Reflux Esophagitis. Completed, enrolled 540 participants across 44 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2008
Enrollment StartJan 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Posted 18.3 years ago

Interventions

Esomeprazoledrug

10mg once daily oral administration

Esomeprazoledrug

20mg once daily oral administration

Omeprazoledrug

10mg once daily oral administration