NCT01734447

Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

Conditions

• Foetal Growth Problem
• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	somatropin	1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
DRUG	somatropin	1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
DRUG	somatropin	2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

Timeline

• Start date: 2000-04-30
• Primary completion: 2003-04-30
• Completion: 2003-04-30
• First posted: 2012-11-27
• Last updated: 2017-02-28

Locations

1 site across 1 country: France