At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Dexlansoprazole MR +1 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 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease
In Brief
A Phase 1 clinical trial evaluating Dexlansoprazole MR for Gastroesophageal Reflux. Completed, enrolled 36 participants across 3 sites.
Detailed Summary
The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMay 2009
Primary CompletionSep 2009
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.4 years ago
Interventions
Dexlansoprazole MRdrug
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
Dexlansoprazole MRdrug
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.