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Effect of Growth Hormone in Children With Growth Hormone Deficiency

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: December 5, 2005
Last updated: January 17, 2017
Last verified: January 2017
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.

Condition Intervention Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Growth Disorder Idiopathic Short Stature Drug: somatropin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in height standard deviation score [ Time Frame: 24 month ]

Secondary Outcome Measures:
  • IGF-I
  • IGFBP-3
  • free IGF-I

Enrollment: 173
Study Start Date: August 2000
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00262249

  Show 40 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00262249     History of Changes
Other Study ID Numbers: HGH-2051
Study First Received: December 5, 2005
Last Updated: January 17, 2017

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Growth Disorders
Pathologic Processes
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on August 18, 2017