NCT00184717

Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)

GHLIQUID-1516: A 104-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 Subjects With Short Stature Born Small for Gestational Age / GHLIQUID-1517: A Long-term, Multi-centre, Randomised, Controlled, Double-blind, Parallel-group Trial, Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan. In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years). Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.

Conditions

• Foetal Growth Problem
• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	somatropin	0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
DRUG	somatropin	0.067 mg/kg/day of NN-220 for s.c. injection in cartridge

Timeline

• Start date: 2004-08-18
• Primary completion: 2006-03-29
• Completion: 2009-12-28
• First posted: 2005-09-16
• Last updated: 2017-07-07
• Results posted: 2011-07-07

Locations

1 site across 1 country: Japan