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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00705172 |
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
Condition | Intervention |
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Prader-Willi Syndrome |
Drug: No treatment given |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader Willi Syndrome (PWS) |
Enrollment: | 41 |
Study Start Date: | March 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
A |
Drug: No treatment given
Prader-Willi syndrome children treated with at least one dose of Norditropin®
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Children with Prader Willi Syndrome
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Arhus N, Denmark, 8200 | |
Germany | |
Hildesheim, Germany, 31134 | |
Switzerland | |
Zürich, Switzerland, 8006 |
Study Director: | Hanne Jørgensen, Msc Pharm | Novo Nordisk |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | GHLIQUID-1961 |
Study First Received: | June 24, 2008 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00705172 History of Changes |
Health Authority: | Germany: Ethics Committee |
Mental Retardation Obesity Genetic Diseases, Inborn Chromosome Disorders Abnormalities, Multiple Nutrition Disorders |
Neurologic Manifestations Overnutrition Prader-Willi Syndrome Congenital Abnormalities Neurobehavioral Manifestations |
Obesity Disease Nervous System Diseases Chromosome Disorders Mental Retardation Pathologic Processes Genetic Diseases, Inborn Syndrome |
Abnormalities, Multiple Neurologic Manifestations Nutrition Disorders Overnutrition Prader-Willi Syndrome Congenital Abnormalities Neurobehavioral Manifestations |