| Trial ID: | L0707 |
| Source ID: | NCT04248335
|
| Associated Drug: |
Pantoprazole
|
| Title: |
Physiologic Determinants of PPI Disposition in Children
|
| Acronym: |
LiverLabPPI
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Pediatric Obesity;NAFLD;GERD
|
| Interventions: |
Drug: Pantoprazole;Drug: Midazolam injection
|
| Outcome Measures: |
plasma pharmacokinetics of pantoprazole;plasma pharmacokinetics of pantoprazole;plasma pharmacokinetics of pantoprazole;plasma pharmacokinetics of pantoprazole;plasma pharmacokinetics of pantoprazole;plasma pharmacokinetics of pantoprazolepharmacodynamics;safety of pantoprazole: incidence of reported and gastrointestinal adverse events;pharmacokinetics of midazolam, if medication received to ease discomfort of pH probe study;urinary metabolites
|
| Sponsor/Collaborators: |
Children's Mercy Hospital Kansas City
|
| Gender: |
All
|
| Age: |
6 Years21 Years
|
| Phases: |
Phase 4
|
| Enrollment: |
150
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
| Start Date: |
27/01/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
22 March 2021
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04248335
|
