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Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

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ClinicalTrials.gov Identifier: NCT01502124
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Drug: somatropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency
Actual Study Start Date : May 8, 2001
Actual Primary Completion Date : March 5, 2003
Actual Study Completion Date : March 5, 2003


Arm Intervention/treatment
Active Comparator: Lyophilized Drug: 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

Experimental: Liquid Drug: somatropin
Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists




Primary Outcome Measures :
  1. Adverse events (especially injection site reactions)
  2. Serious adverse events

Secondary Outcome Measures :
  1. IGF-1 (Insulin-like growth factor 1) concentration
  2. IGFBP-3 (Insulin-like growth factor binding protein 3) concentration


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502124


Locations
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United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90048-1869
United States, Delaware
Novo Nordisk Investigational Site
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Novo Nordisk Investigational Site
Gainesville, Florida, United States, 32608
Novo Nordisk Investigational Site
Miami, Florida, United States, 33155
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32806-1101
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30342
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60612
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60614
United States, Kansas
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67226
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40536-0284
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Novo Nordisk Investigational Site
Worcester, Massachusetts, United States, 01655
United States, New York
Novo Nordisk Investigational Site
Manhasset, New York, United States, 11030
United States, Ohio
Novo Nordisk Investigational Site
Akron, Ohio, United States, 44308-1062
United States, Pennsylvania
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01502124     History of Changes
Other Study ID Numbers: HGH-2124
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs