Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Change from baseline in height SDS (Standard Deviation Score)
Time frame: baseline and 52 weeks
Change from baseline in Lean body mass (g)
Time frame: baseline and 52 weeks
Change from baseline in Percent body fat (%)
Time frame: baseline and 52 weeks
Change from baseline in height velocity (cm/year)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in head circumference (cm)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in cognitive development (score) by Bayley Scale
Time frame: baseline, 28 and 52 weeks
Change from baseline in motor development (score) by Bayley Scale
Time frame: baseline, 28 and 52 weeks
Change from baseline in weight SDS
Time frame: baseline 16, 28 and 52 weeks
Change from baseline in BMI (kg/m2) (Body Mass Index)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in Bone age (month)
Time frame: baseline and 52 weeks
Change from baseline in Bone mineral density (g/cm)
Time frame: baseline and 52 weeks
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Change from baseline in height (cm)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in height SDS
Time frame: baseline, 16 and 28 weeks
Change from baseline in IGF-1 (ng/mL) and IGF-1 SDS
Time frame: baseline, 28, and 52 weeks
Change from baseline in IGFBP-3 (ng/mL) and IGFBP-3 SDS
Time frame: baseline, 28, and 52 weeks