Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Completed · Phase 3

Conditions studied: Growth Hormone Disorder, Growth Hormone Deficiency in Children

In brief

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.

Key facts

Study ID

NCT01502124

Run by

Novo Nordisk A/S

People needed

78

Starts

2001-05-08

Expected to finish

2003-03-05

Last updated by the study team

2017-02-28

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
• Naïve to growth hormone therapy

You may not qualify if…

• Known or suspected allergy to the trial product or related products
• Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
• Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
• Pregnancy or the intention to become pregnant
• Breast-feeding
• Administration of other growth-altering medication

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 — Wilmington, Delaware, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Gainesville, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Wichita, Kansas, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Louisville, Kentucky, United States
• Novo Nordisk Investigational Site — Worcester, Massachusetts, United States
• Novo Nordisk Investigational Site — Manhasset, New York, United States
• Novo Nordisk Investigational Site — Akron, Ohio, United States
• Novo Nordisk Investigational Site — Hershey, Pennsylvania, United States
• Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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