Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Disorder; Growth Hormone Deficiency in Children
Intervention: somatropin (Drug); somatropin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Stephanie Seremetis, MD, Study Director, Affiliation: Novo Nordisk A/S
Summary
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.
Clinical Details
Official title: Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Adverse events (especially injection site reactions)Serious adverse events
Secondary outcome: IGF-1 (Insulin-like growth factor 1) concentrationIGFBP-3 (Insulin-like growth factor binding protein 3) concentration
Eligibility
Minimum age: 3 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90027, United States
Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90048, United States
Novo Nordisk Clinical Trial Call Center, Washington, District of Columbia 20010, United States
Novo Nordisk Clinical Trial Call Center, Gainesville, Florida 32610, United States
Novo Nordisk Clinical Trial Call Center, Miami, Florida 33155, United States
Novo Nordisk Clinical Trial Call Center, Orlando, Florida 32806-1101, United States
Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33607, United States
Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60611, United States
Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60612, United States
Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60614, United States
Novo Nordisk Clinical Trial Call Center, Wichita, Kansas 67211, United States
Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40536-0284, United States
Novo Nordisk Clinical Trial Call Center, Louisville, Kentucky 40202, United States
Novo Nordisk Clinical Trial Call Center, Worcester, Massachusetts 01655, United States
Novo Nordisk Clinical Trial Call Center, Manhasset, New York 11030, United States
Novo Nordisk Clinical Trial Call Center, Akron, Ohio 44308-1062, United States
Novo Nordisk Clinical Trial Call Center, Hershey, Pennsylvania 17033, United States
Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15212, United States
Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15224, United States
Novo Nordisk Clinical Trial Call Center, Seattle, Washington 98105, United States
Additional Information
Clinical Trials at Novo Nordisk
Starting date: May 2001
Last updated: July 11, 2012
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