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Pharmacokinetics of Off Label Pediatric Medications

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ClinicalTrials.gov Identifier: NCT01286519
Recruitment Status : Recruiting
First Posted : January 31, 2011
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease
Off Label Use of Medications in Pediatric Patients

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Off Label Pediatric Medications
Actual Study Start Date : July 2010
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   1 Day to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286519


Contacts
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Contact: Jennifer Talbert, MS, RN (984) 974-7865 jtalbert@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina NC Children's Hospital Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Jennifer Talbert, MS, RN    984-974-7865    jtalbert@med.unc.edu   
Principal Investigator: Matthew M Laughon, MD, MPH         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Matthew M. Laughon, MD, MPH University of North Carolina
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01286519    
Other Study ID Numbers: 10-0865
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
pharmacokinetics