Effect of Obesity on Proton Pump Inhibitors
Phase 4
Completed
NCT04248335
| Condition | Pediatric Obesity, NAFLD, GERD |
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| Phase | Phase 4 |
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| Sponsor | Children's Mercy Hospital Kansas City |
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| Status | Completed |
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| Enrollment | 76 participants |
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| Interventions | Lansoprazole, Pantoprazole, Midazolam |
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| Start date | Jul 3, 2018 |
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| Completion date | Dec 31, 2024 |
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| Results posted | Jun 4, 2026 |
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Summary
This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.
Plasma 1/2 Life (t1/2)
samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug · hours
| Lansoprazole | 1.23 ± 0.77 hours |
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| Pantoprazole | 1.09 ± 1.03 hours |
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Weight-adjusted Clearance
samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug · L//kg/hr
| Lansoprazole | 0.18 ± 0.23 L//kg/hr |
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| Pantoprazole | 0.1 ± 0.06 L//kg/hr |
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AUC
samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug · microgram/mL*h
| Lansoprazole | 3.4 ± 3.5 microgram/mL*h |
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| Pantoprazole | 6.5 ± 7.25 microgram/mL*h |
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Open in BENITIONS
View on ClinicalTrials.gov
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