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Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: May 2026 to May 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2026 to Dec 2027
    • Site details revised
    v16
  2. Re-verified, no change to tracked fieldsv15
  3. Primary completion date: May 2023 to May 2026
    • Study completion date: Dec 2023 to Dec 2026
    v14
  4. Primary completion date: May 2022 to May 2023
    • Study completion date: Dec 2022 to Dec 2023
    v13
  5. Primary completion date: May 2021 to May 2022
    • Study completion date: Dec 2021 to Dec 2022
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: May 2020 to May 2021
    • Study completion date: Dec 2020 to Dec 2021
    v11
  2. Primary completion date: Jul 2019 to May 2020
    • Study completion date: Dec 2019 to Dec 2020
    v10
  3. Primary completion date: Dec 2018 to Jul 2019
    • Study completion date: Dec 2018 to Dec 2019
    v9
  4. Primary completion date: Jun 2018 to Dec 2018v8
  5. Primary completion date: Jun 2017 to Jun 2018
    • Study completion date: Jun 2017 to Dec 2018
    v7
  6. Primary completion date: Oct 2016 to Jun 2017
    • Study completion date: Dec 2016 to Jun 2017
    • Study description expanded, about 302 words
    v6
  7. Primary completion date: Jan 2015 to Oct 2016
    • Study completion date: Jun 2015 to Dec 2016
    v5
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2014 to May 2014
    • Site details revised
    v4
  9. Eligibility criteria revisedv3
  10. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. We would like to find out more about how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, we would like to give oxycodone to surgical patients at Boston Children's Hospital then measure its metabolic activity and also perform a genetic analysis. The genetic testing is specifically to analyze the following genotypes only: cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4), which represent the differences in cytochrome P450 metabolism of oxycodone.
Trial Details
NCT Number NCT02044497
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)		 Pediatric Surgical Patient
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov