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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | Prader-Willi syndrome children treated with at least one dose of Norditropin® |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Change in body composition (DEXA, Bio impedance or stable isotope dilution) |
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Inclusion Criteria:
Exclusion Criteria:
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Children with Prader-Willi Syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arhus N | 8200 | Denmark | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23632904 | Derived | Meinhardt U, Christiansen JS, Farholt S, Lammer C, Ostergaard JR, Schmidt F, Kappelgaard AM, Eiholzer U. The efficacy and safety of long-term Norditropin(R) treatment in children with Prader-Willi syndrome. Horm Metab Res. 2013 Jul;45(7):532-6. doi: 10.1055/s-0033-1343449. Epub 2013 Apr 30. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| 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 |
| Insulin-Like Growth Factor-I (IGF-I) | 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 |
| Hildesheim |
| 31134 |
| Germany |
| Zurich | 8006 | Switzerland |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D025063 | Chromosome Disorders |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |