Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
Phase 3
Completed
- Conditions
- Growth Disorders
- Registration Number
- NCT00174408
- Lead Sponsor
- Pfizer
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Height, height velocity
- Secondary Outcome Measures
Name Time Method Side effects