At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 445 enrolled
Drug / intervention
Dexlansoprazole MR +2 moredrug
Likely dose
Dexlansoprazole MR 30 mgfrom 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.
A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.
In Brief
A Phase 3 clinical trial evaluating Dexlansoprazole MR and Placebo for Esophagitis, Reflux and Esophagitis, Peptic. Completed, enrolled 445 participants across 98 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophagitis, Reflux, Esophagitis, Peptic
CountriesAustralia, Canada, Czechia, Estonia, Latvia, Lithuania, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedMay 2006
Primary CompletionMay 2007
TodayJul 2026
First PostedMay 4, 2006
Enrollment StartMay 1, 2006
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.2 years ago
Interventions
Dexlansoprazole MRdrug
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MRdrug
Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
Placebodrug
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.