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CompletedNCT00262249Updated Jan 18, 2017

Effect of Growth Hormone in Children With Growth Hormone Deficiency

A Phase 3 interventional study of somatropin in Growth Hormone Disorder, Growth Hormone Deficiency in Children and Growth Disorder, sponsored by Novo Nordisk A/S. Completed at 40 sites in United States. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
173
Allocation
Randomized
Ages
3 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Growth Hormone Disorder
  • Growth Hormone Deficiency in Children
  • Growth Disorder
  • Idiopathic Short Stature
03

In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's enrollment of 173 is above the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
173 participants (actual)

Interventions

  • Drugsomatropin
06

What researchers measure

Primary outcomes

  1. Change in height standard deviation score

    Time frame: 24 month

Secondary outcomes

  1. IGF-I

  2. IGFBP-3

  3. free IGF-I

07

Study locations

40 sites
  • Novo Nordisk Investigational Site
    Los Angeles, California 90027, United States
  • Novo Nordisk Investigational Site
    Los Angeles, California 90095, United States
  • Novo Nordisk Investigational Site
    Sacramento, California 95817, United States
  • Novo Nordisk Investigational Site
    San Diego, California 92093, United States
  • Novo Nordisk Investigational Site
    Stanford, California 94305-5208, United States
  • Novo Nordisk Investigational Site
    New Haven, Connecticut 06520, United States
  • Novo Nordisk Investigational Site
    Gainesville, Florida 32608, United States
  • Novo Nordisk Investigational Site
    St. Petersburg, Florida 33701, United States
  • Novo Nordisk Investigational Site
    Tallahassee, Florida 32308, United States
  • Novo Nordisk Investigational Site
    Skokie, Illinois 60077, United States
  • Novo Nordisk Investigational Site
    Indianapolis, Indiana 46202, United States
  • Novo Nordisk Investigational Site
    Iowa City, Iowa 52242, United States
  • Novo Nordisk Investigational Site
    Shreveport, Louisiana 71130-3932, United States
  • Novo Nordisk Investigational Site
    Baltimore, Maryland 21287, United States
  • Novo Nordisk Investigational Site
    Springfield, Massachusetts 01107, United States
  • Novo Nordisk Investigational Site
    Worcester, Massachusetts 01655, United States
  • Novo Nordisk Investigational Site
    Kalamazoo, Michigan 49008, United States
  • Novo Nordisk Investigational Site
    Minneapolis, Minnesota 55416, United States
  • Novo Nordisk Investigational Site
    Minneapolis, Minnesota 55455, United States
  • Novo Nordisk Investigational Site
    Kansas City, Missouri 64108, United States
  • Novo Nordisk Investigational Site
    Morristown, New Jersey 07962, United States
  • Novo Nordisk Investigational Site
    Bronx, New York 10467, United States
  • Novo Nordisk Investigational Site
    Brooklyn, New York 11219, United States
  • Novo Nordisk Investigational Site
    Buffalo, New York 14222, United States
  • Novo Nordisk Investigational Site
    New Hyde Park, New York 11042, United States
  • Novo Nordisk Investigational Site
    New York, New York 10029, United States
  • Novo Nordisk Investigational Site
    Stony Brook, New York 11794, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45229, United States
  • Novo Nordisk Investigational Site
    Cleveland, Ohio 44106, United States
  • Novo Nordisk Investigational Site
    Cleveland, Ohio 44195, United States
  • Novo Nordisk Investigational Site
    Columbus, Ohio 43205, United States
  • Novo Nordisk Investigational Site
    Portland, Oregon 97239, United States
  • Novo Nordisk Investigational Site
    Hershey, Pennsylvania 17033, United States
  • Novo Nordisk Investigational Site
    Philadelphia, Pennsylvania 19104, United States
  • Novo Nordisk Investigational Site
    Charleston, South Carolina 29425, United States
  • Novo Nordisk Investigational Site
    Columbia, South Carolina 29203, United States
  • Novo Nordisk Investigational Site
    Memphis, Tennessee 38103, United States
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78284, United States
  • Novo Nordisk Investigational Site
    Seattle, Washington 98105, United States
  • Novo Nordisk Investigational Site
    Milwaukee, Wisconsin 53226-0509, United States
08

References and documents

Publications

  • Cohen P, Rogol AD, Howard CP, Bright GM, Kappelgaard AM, Rosenfeld RG; American Norditropin Study Group. Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study. J Clin Endocrinol Metab. 2007 Jul;92(7):2480-6. doi: 10.1210/jc.2007-0204. Epub 2007 Mar 13. PubMed 17356043 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00262249
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 6, 2005
Start date
Aug 2000
Primary completion
May 2004
Completion
May 2004
Last update
Jan 18, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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