Growth Disorders
Conditions
Brief summary
The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)
Interventions
DRUGGenotropin
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Birth length below -2 SD * Height at start below - 2 Sd
Exclusion criteria
* Any endocrine or chronic disease * Any known syndrome with short stature
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height, height velocity | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects | — |
Outcome results
None listed