Somatropin (Norditropin) in Insulin-Like Growth Factor (IGF) Deficient Children

Condition(s) targeted: Dwarfism, Pituitary

Intervention: Somatropin (Norditropin®) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk

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

This trial is conducted in the United States of America (USA).

This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.

Official title: Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 12 month change in height standard deviation score.

Secondary outcome: 12 month change in height standard deviation score adjusted for parent height z-score

Minimum age: 3 Years. Maximum age: 13 Years. Gender(s): Both.

Criteria:

Ages 3-15, presence of growth failure indicated by height standard deviation score less

than equal to - 2, body mass index greater than or equal to 25th percentile for height age,

IGF concentration less than or equal to 33rd percentile

Los Angeles, California 90057, United States

San Diego, California 92123, United States

Stanford, California 94305, United States

Tallahassee, Florida 32308, United States

Tampa, Florida 33607, United States

St. Petersburg, Florida 33701, United States

Indianapolis, Indiana 46202, United States

Boston, Massachusetts 02115, United States

Worcester, Massachusetts 01655, United States

Kalamazoo, Michigan 49008, United States

Minneapolis, Minnesota 55416, United States

Kansas City, Missouri 64108, United States

Columbia, Missouri 65212, United States

Buffalo, New York 10422, United States

Bronx, New York 10467, United States

Brooklyn, New York 11219, United States

Cincinnati, Ohio 45229, United States

Akron, Ohio 44308, United States

Oklahoma City, Oklahoma 731034, United States

Hershey, Pennsylvania 17033, United States

Philadelphia, Pennsylvania 19107, United States

Pittsburgh, Pennsylvania 15213, United States

San Antonio, Texas 78237, United States

Seattle, Washington 98104, United States

Milwaukee, Wisconsin 53209, United States

Starting date: June 2003
Last updated: January 29, 2007