Effect of Growth Hormone in Children With Growth Hormone Deficiency

Completed · Phase 3

Conditions studied: Growth Hormone Disorder, Growth Hormone Deficiency in Children, Growth Disorder, Idiopathic Short Stature

In brief

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.

Key facts

Study ID

NCT00262249

Run by

Novo Nordisk A/S

People needed

173

Starts

2000-08-01

Expected to finish

2004-05-01

Last updated by the study team

2017-01-18

Who can join

Age: 3 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Sacramento, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Stanford, California, United States
• Novo Nordisk Investigational Site — New Haven, Connecticut, United States
• Novo Nordisk Investigational Site — Gainesville, Florida, United States
• Novo Nordisk Investigational Site — St. Petersburg, Florida, United States
• Novo Nordisk Investigational Site — Tallahassee, Florida, United States
• Novo Nordisk Investigational Site — Skokie, Illinois, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Shreveport, Louisiana, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Springfield, Massachusetts, United States
• Novo Nordisk Investigational Site — Worcester, Massachusetts, United States
• Novo Nordisk Investigational Site — Kalamazoo, Michigan, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Kansas City, Missouri, United States
• Novo Nordisk Investigational Site — Morristown, New Jersey, United States
• Novo Nordisk Investigational Site — Brooklyn, New York, United States
• Novo Nordisk Investigational Site — Buffalo, New York, United States
• Novo Nordisk Investigational Site — New Hyde Park, New York, United States
• Novo Nordisk Investigational Site — New York, New York, United States

Full record on ClinicalTrials.gov

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