Effect of Growth Hormone in Children With Growth Hormone Deficiency
1 other identifier
interventional
173
1 country
40
Brief Summary
This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone 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 Aug 2000
Typical duration for phase_3
40 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
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 5, 2005
CompletedFirst Posted
Study publicly available on registry
December 6, 2005
CompletedJanuary 18, 2017
January 1, 2017
3.8 years
December 5, 2005
January 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in height standard deviation score
24 month
Secondary Outcomes (3)
IGF-I
IGFBP-3
free IGF-I
Interventions
Eligibility Criteria
You may qualify if:
- Clinically suspected GHD
- Height \< -2.0 SDS
- Serum IGF-I less than or equal to -1.0 SDS
- Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls.
- Puberty Tanner Stage I
You may not qualify if:
- Previous use of growth hormone
- Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
- Intrauterine growth retardation: birth weight \< 3rd percentile.
- Administration of other growth-altering medications.
- Evidence of any malignancy or intracranial tumors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (40)
Novo Nordisk Investigational Site
Los Angeles, California, 90027, United States
Novo Nordisk Investigational Site
Los Angeles, California, 90095, United States
Novo Nordisk Investigational Site
Sacramento, California, 95817, 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
New Haven, Connecticut, 06520, United States
Novo Nordisk Investigational Site
Gainesville, Florida, 32608, 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
Skokie, Illinois, 60077, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46202, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242, United States
Novo Nordisk Investigational Site
Shreveport, Louisiana, 71130-3932, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, 21287, United States
Novo Nordisk Investigational Site
Springfield, Massachusetts, 01107, 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
Minneapolis, Minnesota, 55455, United States
Novo Nordisk Investigational Site
Kansas City, Missouri, 64108, United States
Novo Nordisk Investigational Site
Morristown, New Jersey, 07962, 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
New Hyde Park, New York, 11042, United States
Novo Nordisk Investigational Site
New York, New York, 10029, United States
Novo Nordisk Investigational Site
Stony Brook, New York, 11794, United States
Novo Nordisk Investigational Site
The Bronx, New York, 10467, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45229, United States
Novo Nordisk Investigational Site
Cleveland, Ohio, 44106, United States
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195, United States
Novo Nordisk Investigational Site
Columbus, Ohio, 43205, United States
Novo Nordisk Investigational Site
Portland, Oregon, 97239, United States
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, 29425, United States
Novo Nordisk Investigational Site
Columbia, South Carolina, 29203, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, 38103, 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 (1)
Cohen P, Rogol AD, Howard CP, Bright GM, Kappelgaard AM, Rosenfeld RG; American Norditropin Study Group. Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study. J Clin Endocrinol Metab. 2007 Jul;92(7):2480-6. doi: 10.1210/jc.2007-0204. Epub 2007 Mar 13.
PMID: 17356043RESULT
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
December 5, 2005
First Posted
December 6, 2005
Study Start
August 1, 2000
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
January 18, 2017
Record last verified: 2017-01