MedTrace Logo

rhGH Therapy on Hepatic Drug Metabolism

NCT00458991 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2017-04-27

No results posted yet for this study

Summary

The purpose of the study is to understand the effect of rhGH therapy on hepatic drug metabolism in children with idiopathic growth hormone deficiency.

Conditions

  • Growth Hormone Deficiency, Dwarfism

Interventions

DRUG

Dextromethorphan and Caffeine

All subjects received standard medical therapy with rhGH and at specified times low doses of the pharmacologic "probes" (e.g., caffeine and dextromethorphan) as surrogate markers to determine CYP450 activity. The only direct treatment effect measured was the biological response to rhGH.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Louisville

    lead OTHER

Principal Investigators

  • Mary J Kennedy, PharmD · Virginia Commonwealth University

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00458991 on ClinicalTrials.gov