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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-6250 | Other Identifier | WHO | |
| JapicCTI-101122 | Registry Identifier | JAPIC |
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This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norditropin® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of suspected serious adverse drug reactions (SADRs) during the study period | after 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of impaired glucose tolerance events during the study period | evaluated after 3 months, 6 months, 1 year and between 2-5 years | |
| Number of other types of adverse events (AEs) during the study period | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study
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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 |
|---|---|---|---|---|---|---|
| Tokyo | 1000005 | Japan |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| 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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| Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density) | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
| Effects of insulin-like growth factor-1 (IGF-I) levels | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
| 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |