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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
Somatropin · 4 trials · 5 indications
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population.
Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population.
Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
| Arm | Type | Description |
|---|---|---|
| Somatropin | EXPERIMENTAL | - |
| Treatment Arm | ACTIVE_COMPARATOR | - |
| Control Arm | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Somatropin | DRUG | Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day |
| Control Arm | OTHER | Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year. |
Inclusion Criteria: * Glucocorticosteroid treatment for 12 months at least * Bone age \< 15 years for a boy and \< 13 years for a girl * Child measured height \< - 2 SD, Child currently treated by GH Exclusion Criteria: * Known diabetes (type 1 or type 2) * A previous history of intolerance or hy...
Somatropin is used for growth hormone deficiency and growth hormone therapy, including growth retardation in children with certain pathological conditions. It is also studied in children born preterm who are appropriate for gestational age and in children with short stature or growth retardation related to glucocorticosteroid therapy.
Somatropin targets the growth hormone receptor (GHR) and acts as an agonist. By binding to GHR, it mimics endogenous growth hormone signaling to support linear growth and metabolic effects in patients with growth hormone deficiency or related growth disorders.
Somatropin is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development program for this growth hormone therapy across the listed endocrine and growth-related indications.
Somatropin is in Phase 3 clinical development. The program includes completed Phase 2 and Phase 3 trials, and it remains an investigational therapy rather than a newly approved product based on this development stage information.
Somatropin has been studied in completed trials including NCT00174460 in children born preterm, NCT00174278 in children with short stature, NCT00163215 in children with endocrine system diseases, and NCT00163189 in children with growth retardation due to glucocorticosteroid therapy.