At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 enrolled
Drug / intervention
Dexlansoprazole +2 moredrug
Likely dose
Not stated in 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 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years
In Brief
A Phase 2 clinical trial evaluating Dexlansoprazole and Placebo for Gastroesophageal Reflux Disease and Erosive Esophagitis. Completed, enrolled 63 participants across 60 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Brazil, Hungary, Italy, Mexico, Poland, Portugal, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionNov 2014
TodayJul 2026
First PostedJul 17, 2012
Enrollment StartJul 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.0 years ago
Interventions
Dexlansoprazoledrug
Dexlansoprazole capsules
Dexlansoprazoledrug
Dexlansoprazole capsules
Placebodrug
Dexlansoprazole placebo-matching capsules