Clinical Trial: Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A 52-week, Multi-centre, Randomised, Double-blind, Parallel-group, no Treatment Controlled (Open-label) Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Short Stature With

Brief Summary: This trial is conducted in Asia. The aim of the trial is to investigate the long-term efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan syndrome.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome:

  • Change in height SDS (Standard Deviation Score) [ Time Frame: Week 0, week 104 ]
  • Change in height SDS (Standard Deviation Score) [ Time Frame: Week 0, week 208 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of treatment emergent adverse events (AEs) [ Time Frame: Weeks 0, Week 104 ]
  • Incidence of treatment emergent adverse events (AEs) [ Time Frame: Weeks 0, Week 208 ]
  • Change in IGF-I (insulin like growth factor I) [ Time Frame: Week 0, week 104 ]
  • Change in IGF-I (insulin like growth factor I) [ Time Frame: Week 0, week 208 ]
  • Change in HbA1c (Glycosylated haemoglobin) [ Time Frame: Week 0, week 104 ]
  • Change in HbA1c (Glycosylated haemoglobin) [ Time Frame: Week 0, week 208 ]


Original Secondary Outcome: Same as current

Information By: Novo Nordisk A/S

Dates:
Date Received: August 20, 2013
Date Started: August 19, 2013
Date Completion: July 5, 2018
Last Updated: May 5, 2017
Last Verified: May 2017