Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children
Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.
1 other identifier
interventional
149
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2003
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 1, 2005
CompletedFirst Posted
Study publicly available on registry
February 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 18, 2017
January 1, 2017
3.6 years
February 1, 2005
January 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in height standard deviation score
12 months
Secondary Outcomes (1)
12 months change in height standard deviation score adjusted for parent height z-score
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (27)
Novo Nordisk Investigational Site
Los Angeles, California, 90027, United States
Novo Nordisk Investigational Site
San Diego, California, 92093, United States
Novo Nordisk Investigational Site
Stanford, California, 94305-5208, United States
Novo Nordisk Investigational Site
St. Petersburg, Florida, 33701, United States
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308, United States
Novo Nordisk Investigational Site
Tampa, Florida, 33607, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46202-5225, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, 02115, United States
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01655, United States
Novo Nordisk Investigational Site
Kalamazoo, Michigan, 49008, United States
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416, United States
Novo Nordisk Investigational Site
Kansas City, Missouri, 64108, United States
Novo Nordisk Investigational Site
Brooklyn, New York, 11219, United States
Novo Nordisk Investigational Site
Buffalo, New York, 14222, United States
Novo Nordisk Investigational Site
Rockville Centre, New York, 11570, United States
Novo Nordisk Investigational Site
The Bronx, New York, 10467, United States
Novo Nordisk Investigational Site
Akron, Ohio, 44308-1062, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45229, United States
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Novo Nordisk Investigational Site
Columbia, South Carolina, 29203, United States
Novo Nordisk Investigational Site
San Antonio, Texas, 78284, United States
Novo Nordisk Investigational Site
Seattle, Washington, 98105, United States
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53226-0509, United States
Related Publications (3)
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
RESULTCohen 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
RESULTCohen 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.
PMID: 22924571DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2005
First Posted
February 2, 2005
Study Start
May 1, 2003
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 18, 2017
Record last verified: 2017-01