Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Genetic Disorder

Prader-Willi Syndrome

Eligibility:

All Genders

Up to 15 years

Brief Summary

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 m...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

November 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2008

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00705172

Start Date

November 1 2008

End Date

November 1 2008

Last Update

November 2 2023

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Arhus N, Denmark, 8200

2

Hildesheim, Germany, 31134

3

Zurich, Switzerland, 8006