Effect of Growth Hormone in Children With Growth Hormone Deficiency
Phase 3
Completed
- Conditions
- Growth DisorderGrowth Hormone DisorderGrowth Hormone Deficiency in ChildrenIdiopathic Short Stature
- Registration Number
- NCT00262249
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in height standard deviation score 24 month
- Secondary Outcome Measures
Name Time Method free IGF-I IGF-I IGFBP-3
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Milwaukee, Wisconsin, United States