Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102817
Recruitment Status : Completed
First Posted : February 2, 2005
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Pituitary Dwarfism Drug: somatropin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.
Study Start Date : May 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006





Primary Outcome Measures :
  1. Change in height standard deviation score [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 12 months change in height standard deviation score adjusted for parent height z-score


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 3-15
  • Presence of growth failure indicated by height standard deviation score less than equal to -2
  • Body mass index greater than or equal to 25th percentile for height age
  • IGF concentration less than or equal to 33rd percentile

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): NCT00102817


Locations
Layout table for location information
United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
Novo Nordisk Investigational Site
San Diego, California, United States, 92093
Novo Nordisk Investigational Site
Stanford, California, United States, 94305-5208
United States, Florida
Novo Nordisk Investigational Site
St. Petersburg, Florida, United States, 33701
Novo Nordisk Investigational Site
Tallahassee, Florida, United States, 32308
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46202-5225
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
Novo Nordisk Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
Novo Nordisk Investigational Site
Kalamazoo, Michigan, United States, 49008
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64108
United States, New York
Novo Nordisk Investigational Site
Bronx, New York, United States, 10467
Novo Nordisk Investigational Site
Brooklyn, New York, United States, 11219
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14222
Novo Nordisk Investigational Site
Rockville Centre, New York, United States, 11570
United States, Ohio
Novo Nordisk Investigational Site
Akron, Ohio, United States, 44308-1062
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Novo Nordisk Investigational Site
Columbia, South Carolina, United States, 29203
United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78284
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98105
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53226-0509
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Cohen P, Rogol A, Kappelgaard A-M, Weng W, Germak J, Rosenfeld RG on behalf of the American Norditropin Study Group. Efficacy of IGF-I Based Growth Hormone (GH) Dose Titration in Non-GH Deficient (Non-GHD) Children with Short Stature Associated with IGF-I Deficiency (IGFD). Pediatric Academic Societies (PAS)/Lawson Wilkins Pediatric Endocrine Society (LWPES) 2007; Country: Canada City: Toronto
Cohen P, Rosenfeld R, Rogol A, Kappelgaard A-M, Mak C, Germak J. Validation of the Efficacy and Safety of IGF-based Dose-titration in Children with Growth Failure Associated with Non-GH-deficient, IGF-I Deficiency: Results of Clinical Trial HGH 2147 on Behalf of the American Norditropin® Clinical Studies Group. 3rd International Congress of the Growth Hormone Research Society and the IGF Society 2006; Country: Japan City: Kobe

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00102817    
Other Study ID Numbers: HGH-2147
First Posted: February 2, 2005    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Novo Nordisk A/S:
Growth Hormone Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Dwarfism
Dwarfism, Pituitary
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism