CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
commercially available lansoprazole +1 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.

Search/NCT03015610
NCT03015610Phase 3Completed
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Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma

Jason Lang, M.D., M.P.H.·interventional·Posted Jan 10, 2017·Updated Sep 9, 2025

In Brief

A Phase 3 clinical trial evaluating commercially available lansoprazole and matched placebo for Asthma and Gastroesophageal Reflux. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Gastroesophageal Reflux
CountriesUnited States
CollaboratorsThrasher Research Fund, Nemours Children's Clinic

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 10, 2017
Enrollment StartOct 31, 2017
Primary CompletionJan 18, 2024
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9.5 years ago

Interventions

commercially available lansoprazoledrug

these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily lansoprazole for 24 weeks

matched placebodrug

these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily placebo for 24 weeks