At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 104 enrolled
Drug / intervention
Dexlansoprazoledrug
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 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
In Brief
A Phase 2 clinical trial evaluating Dexlansoprazole for Gastroesophageal Reflux Disease. Completed, enrolled 104 participants across 64 sites in 8 countries.
Detailed Summary
The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesBelgium, Brazil, Hungary, Italy, Mexico, Poland, Portugal, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionJan 2014
TodayJul 2026
First PostedJul 17, 2012
Enrollment StartJul 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.0 years ago
Interventions
Dexlansoprazoledrug
Dexlansoprazole delayed-release capsules.