Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Somatropin · 8 trials · 6 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 | - |
| 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 a growth hormone treatment in Phase 3 clinical development for idiopathic short stature, small for gestational age, failure to thrive, growth disorder, growth hormone deficiency, and Turner syndrome. It is being studied for use in children and adults with these endocrine-related growth conditions.
Somatropin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting Phase 3 clinical trials to evaluate the treatment for various growth disorders.
Somatropin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials have been completed, with no active trials currently ongoing for this treatment.
Somatropin has been studied in four completed Phase 3 clinical trials. These include NCT00190658 in patients with SHOX deficiency and Turner syndrome, NCT00191074 in idiopathic short stature, NCT00191360 in adult growth hormone deficiency, and NCT00191529 in short children born small for gestational age.
Somatropin is a form of growth hormone used in clinical trials for various growth disorders. It is being investigated as a treatment for conditions such as idiopathic short stature, Turner syndrome, and growth hormone deficiency, among others.