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Pathogenesis of Adverse Drug Reactions

NCT00224952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 274

Last updated 2017-08-14

Study results available
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Summary

The purpose of the study is to examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species.

Conditions

Interventions

OTHER

No intervention; Urine Collection

Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Utah

    collaborator OTHER

  • University of Louisville

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • J. Steven Leeder, Pharm.D., Ph.D., · Children's Mercy Hospital Kansas City

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00224952 on ClinicalTrials.gov