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Label indication NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and… FDA label
Also known as Somatropin (rDNA origin) for injection, LY137998, Humatrope, LLY137998, Growth hormone
Somatropin · 9 trials · 7 indications
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient's height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.
Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.
SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS \[NCHS\] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS \[Lyon\] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS \[NCHS\] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Control | NO_INTERVENTION | Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| Humatrope | EXPERIMENTAL | Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| Name | Type | Description |
|---|---|---|
| somatropin | DRUG | 0.05 mg/kg/day |
| leuprorelin | DRUG | 11.25 mg/3 months |
| somatropin, rDNA origin, for injection | DRUG | - |
| Somatropin (rDNA origin) for injection | DRUG | - |
| Ethinyl estradiol | DRUG | escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met. |
| Medroxyprogesterone acetate | DRUG | 10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met. |
Inclusion Criteria: * male or female children with ISS * age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys * bone age less than or equal to 12.0 years for girls...
Somatropin is used to treat growth hormone deficiency in adults and growth disorders in children. Its studied indications include adult growth hormone deficiency, growth hormone deficiency, failure to thrive, idiopathic short stature, Turner syndrome in very young girls, and short children born small for gestational age.
Somatropin targets the growth hormone receptor, or GHR, acting as an agonist. By binding and activating GHR, it mimics endogenous growth hormone signaling, which supports linear growth in children and metabolic effects in adults with growth hormone deficiency.
Somatropin is developed by Eli Lilly and Company, which trades under the ticker LLY. The company is listed as the developer of the somatropin products referenced in these clinical programs.
Somatropin is in Phase 3 clinical development for its listed endocrine indications. The programs described here are investigational, and the completed Phase 3 trials evaluated dosing and growth outcomes in growth hormone deficiency, Turner syndrome, idiopathic short stature, and small for gestational age.
Somatropin has been studied in completed Phase 3 trials including NCT00570011 in growth hormone deficient adults, NCT00406926 in very young girls with Turner syndrome, NCT00355030 in pubertal children with idiopathic short stature, and NCT00191529 in short children born small for gestational age.
Yes. Somatropin is also known as somatropin, rDNA origin, for injection, somatropin, rDNA origin, and Somatropin (rDNA origin) for injection. These names refer to the same recombinant human growth hormone product, so searches using any of these terms point to the same asset.