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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: Recruiting Phase 4 study of Pediatric Surgical Patient, sponsored by Boston Children's Hospital.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Oxycodone, oxymorphone, noroxymorphone and noroxycodone levels, at 10 time points, will be used to determine the single-dose Pharmacokinetics (PK) metric.
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 |
What NCT02044497 shows while recruiting
NCT02044497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02044497's enrollment target sits among peer trials
68 1076th of 2000 higher than 919 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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