NCT01110928

Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 227 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).

Conditions

• Foetal Growth Problem
• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	somatropin	Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.

Timeline

• Start date: 2009-11-26
• Primary completion: 2018-11-12
• Completion: 2018-11-12
• First posted: 2010-04-27
• Last updated: 2019-01-11

Locations

1 site across 1 country: Japan