At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 591 enrolled
Drug / intervention
Dexlansoprazole MR +1 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, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
In Brief
A Phase 3 clinical trial evaluating Dexlansoprazole MR for Gastroesophageal Reflux Disease. Completed, enrolled 591 participants across 181 sites.
Detailed Summary
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2005
Enrollment StartJan 2006
Primary CompletionJun 2008
TodayJul 2026
First PostedNov 17, 2005
Enrollment StartJan 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.6 years ago
Interventions
Dexlansoprazole MRdrug
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Dexlansoprazole MRdrug
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.