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

Prader-Willi Syndrome Clinical Trial

Official title:

Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705172
• Other study ID #: GHLIQUID-1961
• Status: Completed
• Start date: November 2008
• Est. completion date: November 2008

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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®

Related Conditions & MeSH terms

• Genetic Diseases, Inborn
• Genetic Disorder
• Prader-Willi Syndrome
• Syndrome

Intervention

Drug:
• somatropin
Prader-Willi syndrome children treated with at least one dose of Norditropin®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Denmark,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective is to investigate changes in height Standard Deviation Score (SDS)		in response to 12 months Norditropin® treatment in children with PWS (referenced to PWS population
Secondary	Changes in height SDS from start of treatment to last observation during Norditropin treatment (referenced to PWS population1)		at 12 months- and at last observation during Norditropin treatment
Secondary	Change in body composition (DEXA, Bio impedance or stable isotope dilution)		at 12 months- and at last observation during Norditropin treatment
Secondary	Height velocity (HV) and change in HV		at 12 months- and at last observation during Norditropin treatment
Secondary	Glycated Fraction of Haemoglobin (HbA1c)		at 12 months- and at last observation during Norditropin treatment
Secondary	Insulin-Like Growth Factor-I (IGF-I)		at 12 months- and at last observation during Norditropin treatment
Secondary	Haematology		at 12 months- and at last observation during Norditropin treatment
Secondary	Thyroid-stimulating hormone (TSH) and active form of free thyroxin		at 12 months- and at last observation during Norditropin treatment
Secondary	Adverse Events.		at 12 months- and at last observation during Norditropin treatment

External Links

•   Clinical Trials at Novo Nordisk