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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1
Arhus N, Denmark, 8200
2
Hildesheim, Germany, 31134
3
Zurich, Switzerland, 8006