Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader Willi Syndrome
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prader-Willi Syndrome
Intervention: No treatment given (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Hanne Jørgensen, Msc Pharm, Study Director, Affiliation: Novo Nordisk A/S
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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 months to seek
approval for Norditropin treatment with Prader Willi Syndrome
Clinical Details
Official title: Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader Willi Syndrome (PWS)
Study design: Other, Retrospective
Primary outcome: Primary objective is to investigate changes in height Standard Deviation Score (SDS)
Secondary outcome: Changes in height SDS from start of treatment to last observation during Norditropin treatment (referenced to PWS population1)Change in body composition (DEXA, Bio impedance or stable isotope dilution) Height velocity (HV) and change in HV Glycated Fraction of Haemoglobin (HbA1c) Insulin-Like Growth Factor-I (IGF-I) Haematology Thyroid-stimulating hormone (TSH) and active form of free thyroxin Adverse Events.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Exclusion Criteria:
- Pre-treatment with other Growth Hormone preparation prior to treatment with
Norditropin®
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Arhus N 8200, Denmark; Recruiting
Hildesheim 31134, Germany; Not yet recruiting
Zürich 8006, Switzerland; Not yet recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: March 2008
Ending date: October 2008
Last updated: October 16, 2008
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