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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004535-38 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose 33 mcg/kg/day | Experimental |
| |
| High dose 66 mcg/kg/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in height SDS (Standard Deviation Score) (referenced to normal population) | From baseline until final height is reached |
| Measure | Description | Time Frame |
|---|---|---|
| Final height SDS (referenced to normal population) | From baseline until final height is reached | |
| Final height SDS (referenced to Noonan population) | From baseline until final height is reached | |
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Inclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Gothenburg | 416 85 | Sweden |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009634 | Noonan Syndrome |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
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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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| somatropin | Drug | Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658. |
|
| Change in height SDS (referenced to Noonan population) |
| From baseline until final height is reached |
| Number of subjects with final height SDS above - 2SDS (reference to normal population) | When final height is reached |
| Proportion of subjects with final height SDS above - 2SDS (reference to normal population) | When final height is reached |
| Adverse events | From baseline until final height is reached |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |