This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.
Novo Nordisk Investigational Site
Busan, South Korea
Novo Nordisk Investigational Site
Daegu, South Korea
Novo Nordisk Investigational Site
Seoul, South Korea
Novo Nordisk Investigational Site
Seoul, South Korea
Height Velocity (Ht-V)
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.
Time frame: After 6 months of treatment
Change in Ht-SDS (Height Standard Deviation Score)
Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.
Time frame: After 6 months of treatment.
Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)
IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.
Time frame: After 6 months of treatment.
Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)
IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.
Time frame: After 6 months of treatment.
Change in Bone Age
Change in bone age from the baseline to 6 months.
Time frame: After 6 months of treatment.
Occurrence of Adverse Events
AEs were collected throughout the trial in both groups.
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Novo Nordisk Investigational Site
Seoul, South Korea
Novo Nordisk Investigational Site
Seoul, South Korea
Novo Nordisk Investigational Site
Seoul, South Korea
Novo Nordisk Investigational Site
Suwon, South Korea
Time frame: Throughout the trial (12 months)
Ht-V (Height Velocity)
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.
Time frame: At the first 6 months and the last 6 months in group A