Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

Condition(s) targeted: Idiopathic Short Stature

Intervention: Genotropin (Drug); Genotropin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th

percentile (%), or - 1. 3 SDS) during 24 months of treatment. The endpoint at 4 years is to

explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Official title: A Four-Year Open-Label Multi-Center Randomized Two-Arm Study Of Genotropin In Idiopathic Short Stature Patients: Comparing An Individualized, Target-Driven Treatment Regimen To Standard Dosing Of Genotropin

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment

Secondary outcome:

More uniformly achieve the desired height gain at 24 months with the goal of minimizing the variability between subjects.

Demonstrate safety of Genotropin treatment with this treatment paradigm

Identify pharmacogenomic variants related to growth/stature

Explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Explore maintained treatment efficacy at four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Minimum age: 3 Years. Maximum age: 10 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and

9 years of age for females

- Naive to Growth Hormone treatment

Exclusion Criteria:

- Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Little Rock, Alaska 72202, United States; Recruiting

Pfizer Investigational Site, Los Angeles, California 90027, United States; Recruiting

Pfizer Investigational Site, San Diego, California 32123-4282, United States; Recruiting

Pfizer Investigational Site, San Diego, California 92123, United States; Recruiting

Pfizer Investigational Site, Denver, Colorado 800218, United States; Recruiting

Pfizer Investigational Site, Colorado Springs, Colorado 80909, United States; Recruiting

Pfizer Investigational Site, Grand Junction, Colorado 81506, United States; Recruiting

Pfizer Investigational Site, Greenwood Village, Colorado 80111, United States; Recruiting

Pfizer Investigational Site, Longmont, Colorado 80501, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33136, United States; Recruiting

Pfizer Investigational Site, Lake Mary, Florida 32746, United States; Recruiting

Pfizer Investigational Site, Orlando, Florida 32801, United States; Recruiting

Pfizer Investigational Site, Orlando, Florida 32806, United States; Recruiting

Pfizer Investigational Site, Tallahassee, Florida 32308, United States; Recruiting

Pfizer Investigational Site, Hollywood, Florida 33021, United States; Recruiting

Pfizer Investigational Site, Pembroke Pines, Florida 33028, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33155, United States; Recruiting

Pfizer Investigational Site, Iowa City, Iowa 52242, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21201, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21205, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21287, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02114, United States; Recruiting

Pfizer Investigational Site, Springfield, Massachusetts 01199, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02115, United States; Recruiting

Pfizer Investigational Site, Kansas City, Missouri 64108, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63141, United States; Recruiting

Pfizer Investigational Site, Livingston, New Jersey 07039, United States; Recruiting

Pfizer Investigational Site, Morristown, New Jersey 07962, United States; Recruiting

Pfizer Investigational Site, Mineola, New York 11501, United States; Recruiting

Pfizer Investigational Site, BROOKLYN, New York 11219, United States; Recruiting

Pfizer Investigational Site, New Hyde Park, New York 11042, United States; Recruiting

Pfizer Investigational Site, Sleepy Hollow, New York 10591, United States; Recruiting

Pfizer Investigational Site, Buffalo, New York 14222, United States; Recruiting

Pfizer Investigational Site, New York, New York 10029-6789, United States; Recruiting

Pfizer Investigational Site, Bronx, New York 10467-2490, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43205, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43235, United States; Recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15213, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19107, United States; Recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15218, United States; Recruiting

Pfizer Investigational Site, Charleston, South Carolina 29425, United States; Recruiting

Pfizer Investigational Site, Memphis, Tennessee 38119, United States; Recruiting

Pfizer Investigational Site, Nashville, Tennessee 37232, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75230, United States; Recruiting

Pfizer Investigational Site, Fort Worth, Texas 76104, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75235, United States; Recruiting

Pfizer Investigational Site, Cheyenne, Wyoming 82001, United States; Recruiting

Pfizer Investigational Site, Gillette, Wyoming 82716, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2006
Ending date: June 2012
Last updated: August 3, 2008