At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 451 enrolled
Drug / intervention
Dexlansoprazole MR +2 moredrug
Likely dose
Dexlansoprazole MR 60 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 Dexlansoprazole MR (60 mg QD and 90 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 451 participants across 96 sites.
Detailed Summary
The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophagitis, Reflux, Esophagitis, Peptic
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2005
Enrollment StartJan 2006
Primary CompletionNov 2006
TodayJul 2026
First PostedNov 17, 2005
Enrollment StartJan 1, 2006
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 20.6 years ago
Interventions
Dexlansoprazole MRdrug
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MRdrug
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Placebodrug
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.