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Pharmacokinetics of Off Label Pediatric Medications

This study is currently recruiting participants.
Verified September 2017 by University of North Carolina, Chapel Hill
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286519
First Posted: January 31, 2011
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  Purpose
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
Off Label Use of Medications in Pediatric Patients

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Off Label Pediatric Medications

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: The time frame for the outcome measure may vary depending on the length of the course of the medication. However, it would be expected to be approximately 10-21 days. ]
    Area under the curve (AUC), Volume, Distribution, Half life, Clearance, standard SAE and AE reporting per FDA guidelines


Estimated Enrollment: 400
Study Start Date: July 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up 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
  Contacts and Locations
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
Contact: Janice Bernhardt, MS, RN (984) 974-7865 bernhardt@unc.edu

Locations
United States, North Carolina
University of North Carolina NC Children's Hospital Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Janice Bernhardt, MS, RN    984-974-7865    bernhardt@unc.edu   
Principal Investigator: Matthew M Laughon, MD, MPH         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Matthew M. Laughon, MD, MPH University of North Carolina
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01286519     History of Changes
Other Study ID Numbers: 10-0865
First Submitted: January 21, 2011
First Posted: January 31, 2011
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
pharmacokinetics