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

Completed · Phase 3

Conditions studied: Idiopathic Short Stature

In brief

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

Key facts

Study ID

NCT00396097

Run by

Pfizer

People needed

316

Starts

2006-12-01

Expected to finish

2012-08-01

Last updated by the study team

2016-04-05

Who can join

Age: 3 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.

Where it is running

• Arkansas Children's Hospital — Little Rock, Alaska, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• Pediatric Endocrinology of San Diego Medical Group Incorporated — San Diego, California, United States
• Childrens Hospital Colorado — Aurora, Colorado, United States
• Memorial Pediatric Specialty Clinic — Colorado Springs, Colorado, United States
• Pediatric Endocrine Associates — Greenwood Village, Colorado, United States
• Pediatric Endocrine Associates at The Longmont Clinic — Longmont, Colorado, United States
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Miller School Of Medicine, University of Miami/Jackson Memorial Medical Center — Miami, Florida, United States
• Pediatric Endocrinology Associates — Miami, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Nemours Children's Clinic — Orlando, Florida, United States
• Nancy Wright, MD — Tallahassee, Florida, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• University of Maryland Baltimore — Baltimore, Maryland, United States
• Johns Hopkins Pediatric Endocrinology — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Hospital — Boston, Massachusetts, United States
• Baystate Medical Center Children's Hospital — Springfield, Massachusetts, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Children's Endocrine Care of St. Louis, LLC — St Louis, Missouri, United States
• Saint Barnabas Ambulatory Care Center — Livingston, New Jersey, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States

Full record on ClinicalTrials.gov

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