- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00102817
Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children
January 17, 2017 updated by: Novo Nordisk A/S
Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
149
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90027
- Novo Nordisk INvestigational Site
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San Diego, California, United States, 92093
- Novo Nordisk INvestigational Site
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Stanford, California, United States, 94305-5208
- Novo Nordisk INvestigational Site
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Florida
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St. Petersburg, Florida, United States, 33701
- Novo Nordisk INvestigational Site
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Tallahassee, Florida, United States, 32308
- Novo Nordisk INvestigational Site
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Tampa, Florida, United States, 33607
- Novo Nordisk INvestigational Site
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Indiana
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Indianapolis, Indiana, United States, 46202-5225
- Novo Nordisk INvestigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Novo Nordisk INvestigational Site
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Worcester, Massachusetts, United States, 01655
- Novo Nordisk INvestigational Site
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Michigan
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Kalamazoo, Michigan, United States, 49008
- Novo Nordisk INvestigational Site
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Minnesota
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Minneapolis, Minnesota, United States, 55416
- Novo Nordisk INvestigational Site
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Missouri
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Kansas City, Missouri, United States, 64108
- Novo Nordisk INvestigational Site
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New York
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Bronx, New York, United States, 10467
- Novo Nordisk INvestigational Site
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Brooklyn, New York, United States, 11219
- Novo Nordisk INvestigational Site
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Buffalo, New York, United States, 14222
- Novo Nordisk INvestigational Site
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Rockville Centre, New York, United States, 11570
- Novo Nordisk INvestigational Site
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Ohio
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Akron, Ohio, United States, 44308-1062
- Novo Nordisk INvestigational Site
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Cincinnati, Ohio, United States, 45229
- Novo Nordisk INvestigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Novo Nordisk INvestigational Site
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Novo Nordisk INvestigational Site
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Philadelphia, Pennsylvania, United States, 19107
- Novo Nordisk INvestigational Site
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Philadelphia, Pennsylvania, United States, 19104
- Novo Nordisk INvestigational Site
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Pittsburgh, Pennsylvania, United States, 15213
- Novo Nordisk INvestigational Site
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South Carolina
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Columbia, South Carolina, United States, 29203
- Novo Nordisk INvestigational Site
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Texas
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San Antonio, Texas, United States, 78284
- Novo Nordisk INvestigational Site
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Washington
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Seattle, Washington, United States, 98105
- Novo Nordisk INvestigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226-0509
- Novo Nordisk INvestigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in height standard deviation score
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
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12 months change in height standard deviation score adjusted for parent height z-score
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
- Cohen P, Rogol AD, Weng W, Kappelgaard AM, Rosenfeld RG, Germak J; American Norditropin Study Group. Efficacy of IGF-based growth hormone (GH) dosing in nonGH-deficient (nonGHD) short stature children with low IGF-I is not related to basal IGF-I levels. Clin Endocrinol (Oxf). 2013 Mar;78(3):405-14. doi: 10.1111/cen.12014.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
February 1, 2005
First Submitted That Met QC Criteria
February 1, 2005
First Posted (Estimate)
February 2, 2005
Study Record Updates
Last Update Posted (Estimate)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 17, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Pituitary Diseases
- Bone Diseases, Developmental
- Hypopituitarism
- Dwarfism, Pituitary
- Dwarfism
Other Study ID Numbers
- HGH-2147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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