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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00705172

Enrollment

Registered

2008-06-25

Start date

2008-11-30

Completion date

2008-11-30

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Disorder, Prader-Willi Syndrome

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 months to seek approval for Norditropin® treatment with Prader-Willi Syndrome.

Interventions

DRUGsomatropin

Prader-Willi syndrome children treated with at least one dose of Norditropin®

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 15 Years

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®

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change in body composition (DEXA, Bio impedance or stable isotope dilution)	at 12 months- and at last observation during Norditropin treatment
Height velocity (HV) and change in HV	at 12 months- and at last observation during Norditropin treatment
Glycated Fraction of Haemoglobin (HbA1c)	at 12 months- and at last observation during Norditropin treatment
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
Haematology	at 12 months- and at last observation during Norditropin treatment
Thyroid-stimulating hormone (TSH) and active form of free thyroxin	at 12 months- and at last observation during Norditropin treatment
Adverse Events.	at 12 months- and at last observation during Norditropin treatment
Insulin-Like Growth Factor-I (IGF-I)	at 12 months- and at last observation during Norditropin treatment

Countries

Denmark, Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026