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This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyophilized | Active Comparator |
| |
| Liquid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (especially injection site reactions) | ||
| Serious adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 (Insulin-like growth factor 1) concentration | ||
| IGFBP-3 (Insulin-like growth factor binding protein 3) concentration |
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Inclusion Criteria:
Exclusion 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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Los Angeles | California | 90027 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| somatropin | Drug | Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists |
|
| Los Angeles |
| California |
| 90048-1869 |
| United States |
| Novo Nordisk Investigational Site | Wilmington | Delaware | 19899 | United States |
| Novo Nordisk Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| Novo Nordisk Investigational Site | Gainesville | Florida | 32608 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33155 | United States |
| Novo Nordisk Investigational Site | Orlando | Florida | 32806-1101 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33607 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30342 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60612 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60614 | United States |
| Novo Nordisk Investigational Site | Wichita | Kansas | 67226 | United States |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40536-0284 | United States |
| Novo Nordisk Investigational Site | Louisville | Kentucky | 40202 | United States |
| Novo Nordisk Investigational Site | Worcester | Massachusetts | 01655 | United States |
| Novo Nordisk Investigational Site | Manhasset | New York | 11030 | United States |
| Novo Nordisk Investigational Site | Akron | Ohio | 44308-1062 | United States |
| Novo Nordisk Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Novo Nordisk Investigational Site | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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