NCT01927861

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

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 Noonan Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Genetic Disorder
• Noonan Syndrome

Interventions

Type	Name	Description
DRUG	somatropin	Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.

Timeline

• Start date: 2013-08-19
• Primary completion: 2018-07-12
• Completion: 2018-07-12
• First posted: 2013-08-23
• Last updated: 2020-08-10
• Results posted: 2019-10-14

Locations

27 sites across 1 country: Japan