CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

PHASE2RecruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

January 29, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

February 1, 2027

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.

Trial Locations (1)

K1H 8L1

RECRUITING

Children's Hospital of Eastern Ontario, Ottawa

All Listed Sponsors
lead

Children's Hospital of Eastern Ontario

OTHER