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NCT01344200
CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children
Phase 2 trial testing Celecoxib in Pharmacokinetics of Celecoxib in Children in 65 participants. Currently enrolling.
31 January 2026
Quick facts
| Lead sponsor | Children's Hospital of Eastern Ontario |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 29 January 2024 |
| Primary completion | 31 January 2026 |
| Estimated completion | 1 February 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Celecoxib (celecoxib) — full drug profile →
- Placebo
Conditions studied
- Pharmacokinetics of Celecoxib in Children — all drugs for Pharmacokinetics of Celecoxib in Children →
Sponsor
Children's Hospital of Eastern Ontario
Who can join
Adults 2 to 12, any sex, with Pharmacokinetics of Celecoxib in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01344200
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Children's Hospital of Eastern Ontario trials
Trials by the same sponsor.
- NCT06801366 — VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children · recruiting
- NCT06816875 — Comparison of the User Experience of Four Nasal Aspirators in Infants · NA · completed
- NCT06301477 — PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial · NA · active not recruiting
- NCT06232733 — HELP (HEalthy Lifestyles Project) for Youth With Mental Distress · NA · recruiting
- NCT06065215 — Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01344200 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Eastern Ontario
- Last refreshed: 8 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01344200.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing