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

Novo Nordisk

Status: Completed

Conditions: Small for Gestational Age; Foetal Growth Problem

Treatments: Drug: somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT01110928

U1111-1114-6280 (Other Identifier)

JapicCTI-101123 (Registry Identifier)

GH-3812

Details and patient eligibility

About

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).

Enrollment: 227 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in the GHLIQUID-1517 trial
• Patients with SGA (small for gestational age) short stature that are still growing

Exclusion criteria

• Known or suspected allergy to study product(s) or related products
• Diabetes Mellitus
• Patients with malignant tumor(s)
• Pregnant or likely to get pregnant

Trial design

227 participants in 1 patient group

Norditropin®

Treatment:

Drug: somatropin