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Effect of Growth Hormone in Children With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00262249
First received: December 5, 2005
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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)
  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262249

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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:
Dwarfism
Dwarfism, Pituitary
Growth Disorders
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism
 Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013