NCT01286519 · University of North Carolina, Chapel Hill
Pharmacokinetics of Off Label Pediatric Medications
What this study is about
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
View original scientific description
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
Primary outcome measures
Area under the curve (AUC)
Time frame: approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.
actual body exposure to drug after a dose of the drug is administered. this is dependent on on the rate of drug elimination divided by plasma concentration of the drug.
Volume of distribution at steady-state
Time frame: 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 is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.
Terminal elimination rate constant (Ke) and Half-Life
Time frame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Period of time that it takes for the concentration of the drug in the body to be reduced by on-half.
Plasma Clearance
Time frame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
the rate at which the drug is eliminated from the body divided by the plasma concentration.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations