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This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.2, continuous treatment | Experimental |
| |
| 1.2, non-continuous treatment | Experimental |
| |
| 2.4, non-continuous treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | 1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray | ||
| Pubertal development, assessed according to Tanner method | ||
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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 | Paris | France |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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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 | 1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively) |
|
| somatropin | Drug | 2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively) |
|
| Height velocity |
| Final height |
| Number of Adverse Events |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |