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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 16 December 2017
Main ID:  NCT00458991
Date of registration: 09/04/2007
Prospective Registration: No
Primary sponsor: University of Louisville
Public title: rhGH Therapy on Hepatic Drug Metabolism
Scientific title: Recombinant Human Growth Hormone Therapy and Drug Metabolism
Date of first enrolment: June 2001
Target sample size: 9
Recruitment status: Completed
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
United States
Name:     Mary J Kennedy, PharmD
Affiliation:  Virginia Commonwealth University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Children ages 4 to 14 years with a height less than the 5th percentile for age and sex
or having a decelerated across two major percentiles (5th, 10th, 25th, 50th, 90th, and
95th) on standard pediatric growth curves, poor growth velocity (less than 5
centimeters/year), radiographic evidence of delayed bone age (i.e. greater than 1 SD
below the mean for chronological age) and a documented diagnosis of idiopathic growth
hormone deficiency [as determined by failure to raise serum GH concentrations 10
microgram/Liter following provocative testing with two growth hormone
secretagogues(e.g. insulin, arginine, or clonidine)].

- All subjects will be prepubertal, as determined by Tanner staging.

Exclusion Criteria:

- Children receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO,
CYP2D6 or CYP3A4 activity.

- Subjects with a history of smoking (including exposure to second hand smoke > 8 hours
per day) or illicit drug use.

- Subjects with a history of hepatic, renal, cardiac or thyroid disorders. Presence of
hepatic, renal, cardiac or thyroid disease will be established based on clinical
history and results of recent laboratory tests conducted as part of the routine
medical evaluation of children who are being considered for rhGH therapy.

- Children experiencing fever or acute viral illness

- Children who have a history of a hypersensitivity reaction to dextromethorphan or

- Children who have received prior treatment with rhGH

- Children who are receiving corticosteroids or thyroid hormone

Age minimum: 4 Years
Age maximum: 14 Years
Gender: All
Health Condition(s) or Problem(s) studied
Growth Hormone Deficiency, Dwarfism
Drug: Dextromethorphan and Caffeine
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
PPRU 10734
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ethics review
Results available:
Date Posted:
Date Completed:
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