Pharmacokinetics of Off Label Pediatric Medications

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Matthew Laughon, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01286519
First received: January 21, 2011
Last updated: April 22, 2014
Last verified: April 2014
  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. ] [ Designated as safety issue: No ]
    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 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   up to 8 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286519

Contacts
Contact: Janice Bernhardt, MS, RN (919) 843-2373 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    919-843-2373    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

No publications provided

Responsible Party: Matthew Laughon, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01286519     History of Changes
Other Study ID Numbers: 10-0865
Study First Received: January 21, 2011
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014