Effect of Growth Hormone in Children With Growth Hormone Deficiency

Condition(s) targeted: Growth Hormone Deficiency; Idiopathic Short Stature

Intervention: Somatropin [rDNA origin] (Norditropin®) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Campbell Howard, MD, Study Director, Affiliation: Novo Nordisk

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.

Official title: Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature

Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 24 month change in height standard deviation score

Secondary outcome:

IGF-I

IGFBP-3

free IGF-I

Minimum age: 3 Years. Maximum age: 15 Years. Gender(s): Both.

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.

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90095, United States

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90027, United States

Novo Nordisk Clinical Trial Call Center, San Diego, California 92123, United States

Novo Nordisk Clinical Trial Call Center, Orange, California 92868, United States

Novo Nordisk Clinical Trial Call Center, Sacramento, California 95817, United States

Novo Nordisk Clinical Trial Call Center, Stanford, California 94305-5208, United States

Novo Nordisk Clinical Trial Call Center, New Haven, Connecticut 06520, United States

Novo Nordisk Clinical Trial Call Center, St. Petersburg, Florida 33701, United States

Novo Nordisk Clinical Trial Call Center, Tallahassee, Florida 32308, United States

Novo Nordisk Clinical Trial Call Center, Gainesville, Florida 32610, United States

Novo Nordisk Clinical Trial Call Center, Indianapolis, Indiana 46202, United States

Novo Nordisk Clinical Trial Call Center, Iowa City, Iowa 52242, United States

Novo Nordisk Clinical Trial Call Center, Shreveport, Louisiana 71130, United States

Novo Nordisk Clinical Trial Call Center, Baltimore, Maryland 21287, United States

Novo Nordisk Clinical Trial Call Center, Springfield, Massachusetts 01107, United States

Novo Nordisk Clinical Trial Call Center, Worcester, Massachusetts 01655, United States

Novo Nordisk Clinical Trial Call Center, Kalamazoo, Michigan 49008, United States

Novo Nordisk Clinical Trial Call Center, Minneapolis, Minnesota 55416, United States

Novo Nordisk Clinical Trial Call Center, Kansas City, Missouri 64108, United States

Novo Nordisk Clinical Trial Call Center, Morristown, New Jersey 07962, United States

Novo Nordisk Clinical Trial Call Center, Brooklyn, New York 11219, United States

Novo Nordisk Clinical Trial Call Center, Buffalo, New York 14222, United States

Novo Nordisk Clinical Trial Call Center, New York, New York 10029-6574, United States

Novo Nordisk Clinical Trial Call Center, Bronx, New York 10467, United States

Novo Nordisk Clinical Trial Call Center, Stony Brook, New York 11794-8111, United States

Novo Nordisk Clinical Trial Call Center, Cincinnati, Ohio 45229-3039, United States

Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44106, United States

Novo Nordisk Clinical Trial Call Center, Columbus, Ohio 43205-2696, United States

Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44195, United States

Novo Nordisk Clinical Trial Call Center, Portland, Oregon 97239, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19104, United States

Novo Nordisk Clinical Trial Call Center, Hershey, Pennsylvania 17033, United States

Novo Nordisk Clinical Trial Call Center, Columbia, South Carolina 29203, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78230, United States

Novo Nordisk Clinical Trial Call Center, Seattle, Washington 98105, United States

Novo Nordisk Clinical Trial Call Center, Milwaukee, Wisconsin 53226, United States

Starting date: March 2000
Last updated: December 5, 2005