Effect of Growth Hormone in Children With Growth Hormone Deficiency

This study has been completed.

First Received: December 5, 2005 Last Updated: October 1, 2009 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00262249

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 Deficiency (GHD) Idiopathic Short Stature	Drug: somatropin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

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

Locations

United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103

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:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	HGH-2051
Study First Received:	December 5, 2005
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00262249 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases

Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on February 08, 2010