drugset / Trial / NCT01344200

CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

NCT01344200

Phase 2 Recruiting 65 enrolled Children's Hospital of Eastern Ontario
RandomizedParallel-groupTriple-blindTreatment

Summary

Celecoxib is effective for reducing postoperative pain in adults. Children use celecoxib more rapidly than adults and require higher doses. Celecoxib is partially metabolized in the liver by a certain enzyme. A person's genetic variation of this enzyme can influence how well their body uses Celecoxib. Furthermore, Celecoxib down-regulates P-glycoprotein (P-gp), a drug efflux transporter located at the blood brain barrier responsible for central nervous system (CNS) extrusion of ondansetron and possibly fentanyl; therefore celecoxib may augment the CNS effects of these drugs. Understanding the blood and cerebrospinal fluid (CSF) profile of celecoxib in children and the influence of genetics on metabolism would help to develop appropriate celecoxib dosing in children for various treatment options.

Timeline

Start
2024-01-29
Primary completion
2026-01-31
Completion
2027-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 7 mg/kg Oral
Comparator Celecoxib Other / unclassified 14 mg/kg Oral

Indications

No indication recorded.