French National Registry of Children Born Small for Gestational Age Treated With Somatropin

Novo Nordisk

Status: Completed

Conditions: Small for Gestational Age; Growth Disorder

Treatments: Drug: somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT01578135

GHSGA-1757

Details and patient eligibility

About

This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)

Enrollment: 291 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Born small for gestational age

Trial design

291 participants in 2 patient groups

Phase I

Treatment:

Drug: somatropin

Drug: somatropin

Phase II

Treatment:

Drug: somatropin

Drug: somatropin