Effect of Growth Hormone in Children With Growth Hormone Deficiency

This study has been completed.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: December 5, 2005
Last updated: July 10, 2012
Last verified: July 2012

This trial was conducted in the United States of America (USA). The purpose of the trial was 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IGF-I [ Designated as safety issue: No ]
  • IGFBP-3 [ Designated as safety issue: No ]
  • free IGF-I [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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 ClinicalTrials.gov identifier: NCT00262249

  Show 35 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Campbell Howard, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00262249     History of Changes
Other Study ID Numbers: HGH-2051
Study First Received: December 5, 2005
Last Updated: July 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Growth Disorders
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
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014