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NCT02044497 · ClinicalTrials.gov registry record · Phase 4
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
A Phase 4 study of Pediatric Surgical Patient, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT02044497 is a Phase 4 study of Pediatric Surgical Patient that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 68 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02044497, a Phase 4 study of Pediatric Surgical Patient, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG oral oxycodone
Study Locations (1)
Massachusetts
- Boston Children Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2014-05 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02044497
The ClinicalTrials.gov registry entry for NCT02044497 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pediatric Surgical Patient appearing as the primary indexed condition, and to 1 intervention - of which oral oxycodone is the first listed.
NCT02044497 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02044497 about?
NCT02044497 is a clinical study titled "Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients". 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) a...
What is the current status of trial NCT02044497?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2014-05. Estimated completion is 2026-12.
What conditions does trial NCT02044497 study?
This clinical trial studies the following conditions: Pediatric Surgical Patient.
What interventions are being tested in trial NCT02044497?
The interventions under investigation include: oral oxycodone (DRUG).
Who is sponsoring clinical trial NCT02044497?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02044497 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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