Actively Recruiting
CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children
Led by Children's Hospital of Eastern Ontario · Updated on 2024-02-08
65
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 12 years
- Undergoing maintenance chemotherapy for hematological malignancies or lymphomas (acute lymphoblastic leukemia and lymphoblastic lymphomas)
- Patients who have achieved remission approximately 6 months earlier
You will not qualify if you...
- Younger than 2 years or older than 12 years
- Children with non-hematologic cancers
- Diagnosis of acute myeloid leukemia (AML)
- Undergoing bone marrow aspiration only
- Serum creatinine greater than twice the upper normal limit within 30 days
- Abnormal liver function tests (ALT, AST, total or direct bilirubin greater than twice the upper normal limit) within 30 days
- History of peptic ulcer disease
- Allergy to celecoxib or NSAIDs (excluding sulpha allergy)
- Recent celecoxib use within 7 days
- Taking CYP2C9 inhibitors such as fluconazole, amiodarone, or oxandrolone
- Taking CYP2C9 inducers such as rifampin or phenobarbitol
- Receiving high (≥ 5 gm/m2) or escalating doses of methotrexate
- Body mass index below 5th percentile or above 95th percentile
- Parents unable to understand instructions in English or French
- Participant or parents with dementia, psychosis, or cognitive impairment preventing informed consent or study participation
- Currently enrolled in another clinical trial
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
Research Team
D
Dr Kimmo Murto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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