NCT04248335

Effect of Obesity on Proton Pump Inhibitors

Physiologic Determinants of PPI Disposition in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Accepted

Summary

This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.

Detailed description

The purpose of this research study is to see how the body breaks down certain medicines. Many medicines are broken down in the liver. The liver is an organ in the belly. A person's age, size, genetics (DNA), and the health of their liver decide how quickly the body breaks down medicines and how much medication a person needs to take. Everybody's liver has some fat in it, but the amount of fat is different from person to person. The purpose of this study is to see if the amount of fat in the liver affects how quickly acid suppression medications start and stop working and get removed from the body.

Conditions

• Pediatric Obesity
• NAFLD
• GERD

Interventions

Type	Name	Description
DRUG	Pantoprazole	single-dose administration
DRUG	Midazolam injection	single-dose administration

Timeline

• Start date: 2018-07-03
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-01-30
• Last updated: 2025-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study