Clinical Trial

CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

Recruiting Phase 2
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Record status
This record was last updated February 8, 2024 (before its estimated January 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2011-04-28; most recent amendment 2024-02-07.
Status change: Not Yet Recruiting → Recruiting 2024-02-07
Status change: Active, Not Recruiting → Not Yet Recruiting 2013-04-17
Trial Details
NCT Number NCT01344200
Lead Sponsor Children's Hospital of Eastern Ontario
Conditions Pharmacokinetics of Celecoxib in Children
Enrollment 65 participants
Start Date 2024-01-29
Primary Completion 2026-01-31 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2024-02-08