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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Genetic Disorder Prader-Willi Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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A

somatropin

Intervention Type DRUG

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

Interventions

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somatropin

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

Intervention Type DRUG

Other Intervention Names

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Norditropin®

Eligibility Criteria

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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)