MedTrace Logo

CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

NCT01344200 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-02-08

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics of Celecoxib in Children

Interventions

DRUG

Celecoxib

In Phase I twenty (20) children will receive either celecoxib 14 or 7 mg/kg 120-180 minutes prior to lumbar puncture (LP). In Phase II forty-five (45) children will receive celecoxib 14 mg/kg, 7 mg/kg or placebo in one of 5 time intervals, 1-24 hours prior to LP.

DRUG

Placebo

In Phase II forty-five (45) children will receive celecoxib 14 mg/kg, 7 mg/kg or placebo in one of 5 time intervals, 1-24 hours prior to LP.

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    lead OTHER

Principal Investigators

  • Dr Kimmo Murto, MD · Children's Hospital of Eastern Ontario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344200 on ClinicalTrials.gov