Clinical Trial: Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 12-month, Open-labelled, Randomised, Parallel-group, Multi-centre, Interventional Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone (hGH) (Norditropin® Nordilet®

Brief Summary: 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.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: Height Velocity (Ht-V) [ Time Frame: After 6 months of treatment ]

Original Primary Outcome: Change in height velocity (Ht-V) [ Time Frame: From day 0 to the end of treatment (month 6) ]

Current Secondary Outcome:

• Change in Ht-SDS (Height Standard Deviation Score) [ Time Frame: After 6 months of treatment. ]
  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.
• Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I) [ Time Frame: After 6 months of treatment. ]
  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.
• Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3) [ Time Frame: After 6 months of treatment. ]
  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.
• Change in Bone Age [ Time Frame: After 6 months of treatment. ]
  Change in bone age from the baseline to 6 months.
• Occurrence of Adverse Events [ Time Frame: Throughout the trial (12 months) ]
  AEs were collected throughout the trial in both groups.
• Ht-V (Height Velocity) [ Time Frame: At the first 6 months and the last 6 months in group A ]
  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.

Original Secondary Outcome:

• Change in Ht-SDS (Height Standard Deviation Score) [ Time Frame: From day 0 to the end of treatment (month 6) ]
• Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I) [ Time Frame: From day 0 to the end of treatment (month 6) ]
• Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3) [ Time Frame: From day 0 to the end of treatment (month 6) ]
• Change for bone age [ Time Frame: From day 0 to the end of treatment (month 6) ]
• Occurrence of Adverse Events [ Time Frame: From day 0 through month 6 ]
• Ht-V (Height Velocity) [ Time Frame: At the first 6 months and the last 6 months of group A ]

Dates:
Date Received: January 24, 2013
Date Started: January 2013
Date Completion:
Last Updated: January 12, 2017
Last Verified: January 2017