NCT00174408
Completed
Phase 3
Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)
ConditionsGrowth Disorders
DrugsGenotropin
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Growth Disorders
- Sponsor
- Pfizer
- Enrollment
- 110
- Primary Endpoint
- Height, height velocity
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Height, height velocity
Secondary Outcomes
- Side effects
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