Effect of Growth Hormone in Children With Growth Hormone Deficiency

Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00262249

Enrollment

173

Registered

2005-12-06

Start date

2000-08-31

Completion date

2004-05-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Disorder, Growth Hormone Deficiency in Children, Growth Hormone Disorder, Idiopathic Short Stature

Brief summary

This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

Interventions

DRUGsomatropin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 15 Years

Healthy volunteers

Inclusion criteria

* Clinically suspected GHD * Height \< -2.0 SDS * Serum IGF-I less than or equal to -1.0 SDS * Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls. * Puberty Tanner Stage I

Exclusion criteria

* Previous use of growth hormone * Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.) * Intrauterine growth retardation: birth weight \< 3rd percentile. * Administration of other growth-altering medications. * Evidence of any malignancy or intracranial tumors.

Design outcomes

Primary

Measure	Time frame
Change in height standard deviation score	24 month

Secondary

Measure	Time frame
IGF-I	—
IGFBP-3	—
free IGF-I	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026