This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Novo Nordisk Investigational Site
Barakaldo, Spain
Novo Nordisk Investigational Site
Barcelona, Spain
Novo Nordisk Investigational Site
Cadiz, Spain
Effect on Efficacy: Height SDS for chronological age
Time frame: after 48 months
Safety: Bone maturation and glucose metabolism
Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels
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Novo Nordisk Investigational Site
Córdoba, Spain
Novo Nordisk Investigational Site
El Palmar, Spain
Novo Nordisk Investigational Site
Esplugues Llobregat, Spain
Novo Nordisk Investigational Site
Granada, Spain
Novo Nordisk Investigational Site
Madrid, Spain
Novo Nordisk Investigational Site
Madrid, Spain
Novo Nordisk Investigational Site
Málaga, Spain
...and 3 more locations