RecruitingNot Applicable

Pharmacokinetics of Off Label Pediatric Medications

United States400 participantsStarted 2010-07

Plain-language summary

The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.

Who can participate

Age range

1 Day – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children less than 8 years of age * Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care Exclusion Criteria: * Lack of consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the curve (AUC)

Timeframe: approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.

Volume of distribution at steady-state

Timeframe: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.

Terminal elimination rate constant (Ke) and Half-Life

Timeframe: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.

Plasma Clearance

Timeframe: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.

Trial details

NCT IDNCT01286519

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2035-12

Contact for this trial

Sneha Makhijani, BS

(984) 974-7865 sneha_makhijani@med.unc.edu

View on ClinicalTrials.gov More Off Label Use of Medications in Pediatric Patients trials

Who can participate

Age range

1 Day – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area under the curve (AUC)

Timeframe: approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.

Volume of distribution at steady-state

Timeframe: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.

Terminal elimination rate constant (Ke) and Half-Life

Timeframe: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.

Plasma Clearance

Timeframe: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.