Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
NCT ID: NCT01502124
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
78 participants
INTERVENTIONAL
2001-05-08
2003-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lyophilized
somatropin
Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
Liquid
somatropin
Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
Interventions
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somatropin
Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
somatropin
Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
Eligibility Criteria
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Inclusion Criteria
* Naïve to growth hormone therapy
Exclusion Criteria
* 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
3 Years
17 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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HGH-2124
Identifier Type: -
Identifier Source: org_study_id
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