Growth Hormone Disorder, Pituitary Dwarfism
Conditions
Keywords
Growth Hormone Disorder
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.
Interventions
DRUGsomatropin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height standard deviation score | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 12 months change in height standard deviation score adjusted for parent height z-score | — |
Countries
United States
Outcome results
None listed