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This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in height standard deviation score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12 months change in height standard deviation score adjusted for parent height z-score |
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Los Angeles | California | 90027 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Cohen P, Rogol A, Kappelgaard A-M, Weng W, Germak J, Rosenfeld RG on behalf of the American Norditropin Study Group. Efficacy of IGF-I Based Growth Hormone (GH) Dose Titration in Non-GH Deficient (Non-GHD) Children with Short Stature Associated with IGF-I Deficiency (IGFD). Pediatric Academic Societies (PAS)/Lawson Wilkins Pediatric Endocrine Society (LWPES) 2007; Country: Canada City: Toronto | ||
| Result | Cohen P, Rosenfeld R, Rogol A, Kappelgaard A-M, Mak C, Germak J. Validation of the Efficacy and Safety of IGF-based Dose-titration in Children with Growth Failure Associated with Non-GH-deficient, IGF-I Deficiency: Results of Clinical Trial HGH 2147 on Behalf of the American Norditropin® Clinical Studies Group. 3rd International Congress of the Growth Hormone Research Society and the IGF Society 2006; Country: Japan City: Kobe | ||
| 22924571 | Derived | Cohen P, Rogol AD, Weng W, Kappelgaard AM, Rosenfeld RG, Germak J; American Norditropin Study Group. Efficacy of IGF-based growth hormone (GH) dosing in nonGH-deficient (nonGHD) short stature children with low IGF-I is not related to basal IGF-I levels. Clin Endocrinol (Oxf). 2013 Mar;78(3):405-14. doi: 10.1111/cen.12014. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| San Diego |
| California |
| 92093 |
| United States |
| Novo Nordisk Investigational Site | Stanford | California | 94305-5208 | United States |
| Novo Nordisk Investigational Site | St. Petersburg | Florida | 33701 | United States |
| Novo Nordisk Investigational Site | Tallahassee | Florida | 32308 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33607 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46202-5225 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02115 | United States |
| Novo Nordisk Investigational Site | Worcester | Massachusetts | 01655 | United States |
| Novo Nordisk Investigational Site | Kalamazoo | Michigan | 49008 | United States |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55416 | United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64108 | United States |
| Novo Nordisk Investigational Site | Brooklyn | New York | 11219 | United States |
| Novo Nordisk Investigational Site | Buffalo | New York | 14222 | United States |
| Novo Nordisk Investigational Site | Rockville Centre | New York | 11570 | United States |
| Novo Nordisk Investigational Site | The Bronx | New York | 10467 | United States |
| Novo Nordisk Investigational Site | Akron | Ohio | 44308-1062 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45229 | United States |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Novo Nordisk Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Novo Nordisk Investigational Site | Columbia | South Carolina | 29203 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78284 | United States |
| Novo Nordisk Investigational Site | Seattle | Washington | 98105 | United States |
| Novo Nordisk Investigational Site | Milwaukee | Wisconsin | 53226-0509 | United States |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System 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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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