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CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruitingv14 Show 4 more changesShow less
    • Primary completion date: Aug 2024 to Jan 31, 2026
    • Start date changed from estimate of Dec 2022 to Jan 29, 2024
    • Study completion date: Sep 2025 to Feb 1, 2027
    • Site details revised
  2. Primary endpoints: 3 to 4v13 Show 6 more changesShow less
    • Primary completion date: Dec 2024 to Aug 2024
    • Study completion date: Jan 2025 to Sep 2025
    • Start date: Jan 2023 to Dec 2022
    • Eligibility criteria revised
    • Secondary endpoints: 12 to 13
    • Study description shortened, about 29 words
  3. Primary completion date: Dec 2023 to Dec 2024
    • Start date: Jan 2022 to Jan 2023
    • Study completion date: Jan 2024 to Jan 2025
    v12
  4. Start date: Sep 2021 to Jan 2022
    • Primary completion date: Sep 2023 to Dec 2023
    • Study completion date: Dec 2023 to Jan 2024
    v11
  5. Phase: Phase 4 to Phase 2v10 Show 11 more changesShow less
    • Enrollment target: 20 to 65
    • Primary completion date: Dec 2019 to Sep 2023
    • Start date: Mar 2019 to Sep 2021
    • Primary endpoints: 1 to 3
    • Study completion date: Dec 2019 to Dec 2023
    • Interventions: Celecoxib (Drug) to Celecoxib (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 6 to 12
    • Study description expanded, about 370 words
    • Study title shortened, about 6 words
    • Study arms: 2 to 5
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Dec 2018 to Dec 2019
    • Start date: Nov 2018 to Mar 2019
    • Study completion date: Jan 2019 to Dec 2019
    v9
  2. Start date: May 2018 to Nov 2018v8
  3. Primary completion date: May 2017 to Dec 2018
    • Start date: Oct 2016 to May 2018
    • Study completion date: Aug 2017 to Jan 2019
    v7
  4. Primary completion date: Sep 2016 to May 2017
    • Start date: Apr 2016 to Oct 2016
    • Study completion date: Jan 2017 to Aug 2017
    v6
  5. Start date: Jul 2015 to Apr 2016
    • Primary completion date: Jul 2016 to Sep 2016
    v5
  6. Primary completion date: Apr 2014 to Jul 2016
    • Start date: May 2013 to Jul 2015
    • Study completion date: Dec 2014 to Jan 2017
    v4
  7. Start date: Apr 2011 to May 2013
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Site contact updated
    v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01344200
Lead Sponsor Children's Hospital of Eastern Ontario
Conditions
(from sponsor)		 Pharmacokinetics of Celecoxib in Children
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov