Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age

Pfizer

Status and phase: Completed; Phase 3

Conditions: Growth Disorders

Treatments: Drug: Genotropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174408

A6281048

89-041

Details and patient eligibility

About

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)

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)