Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome

Novo Nordisk

Status: Completed

Conditions: Prader-Willi Syndrome; Genetic Disorder

Treatments: Drug: somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT00705172

GHLIQUID-1961

Details and patient eligibility

About

This study is conducted in Europe. The aim of this observational study is to collect data from children with Prader-Willi Syndrome, who have been treated off-label with Norditropin® for more than 12 months to seek approval for Norditropin® treatment with Prader-Willi Syndrome.

Enrollment: 41 patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities
• Genetically diagnosed Prader-Willi Syndrome
• Received at least one dose of Norditropin® treatment
• Pre-pubertal at start of treatment; assessed by Tanner stage 1, or testicular volume below 4ml (according to Tanner 1976)

Exclusion criteria

• Pre-treatment with other Growth Hormone preparation prior to treatment with Norditropin®

Trial design

41 participants in 1 patient group

A

Treatment:

Drug: somatropin