At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Dexlansoprazole +2 moredrug
Likely dose
Dexlansoprazole 15 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 Design, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Delayed Release Capsules in Pediatric Subjects Ages 1 to 11 Years Old With Symptomatic Gastroesophageal Reflux Disease
In Brief
A Phase 1 clinical trial evaluating Dexlansoprazole for Gastroesophageal Reflux. Completed, enrolled 36 participants across 4 sites.
Detailed Summary
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2010
Enrollment StartMar 2010
Primary CompletionFeb 2011
TodayJul 2026
First PostedJan 8, 2010
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.5 years ago
Interventions
Dexlansoprazoledrug
Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazoledrug
Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazoledrug
Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days