drugset / Trial / NCT03015610
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
Phase 3
Completed
41 enrolled
Jason Lang, M.D., M.P.H.
Nemours Children's Clinic · collabThrasher Research Fund · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2017-10-31
- Primary completion
- 2024-01-18
- Completion
- 2024-01-18
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Genotype-guided Lansoprazole; p = 0.8716; Wilcoxon (Mann-Whitney) NCT03015610 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lansoprazole | Other / unclassified | — | Oral |