Off Label Use of Medications in Pediatric PatientsNCT01286519
Pharmacokinetics of Off Label Pediatric Medications
An observational study of Off Label Use of Medications in Pediatric Patients, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 8 years
- Conditions the study is for
- Off Label Use of Medications in Pediatric Patients
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: children < 8 years of age currently receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care
Who may be able to join
- 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
Who cannot join
- Lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina NC Children's Hospital
Chapel Hill, North Carolina, 27514
Sneha Makhijani, MS, RN, 984-974-7865, sneha_makhijani@med.unc.edu
Matthew M Laughon, MD, MPH
About this study
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
Read the detailed description
There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.
- Keywords
- pharmacokinetics
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
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.
Measured: 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
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.
Measured: 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
Period of time that it takes for the concentration of the drug in the body to be reduced by on-half.
Measured: 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
the rate at which the drug is eliminated from the body divided by the plasma concentration.
Measured: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Off Label Use of Medications in Pediatric PatientsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew M. Laughon, MD, MPH, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286519
- Sponsor's protocol ID
- 10-0865
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2011
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Off Label Pediatric Medications
- ClinicalTrials.gov ID
- NCT01286519
- Acronym / sponsor ID
- 10-0865
- Keywords
- pharmacokinetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
Detailed description
There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children < 8 years of age currently receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew M. Laughon, MD, MPH principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Off Label Use of Medications in Pediatric Patients, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sneha Makhijani, BS ((984) 974-7865, sneha_makhijani@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.