Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
somatropin · 22 trials · 17 indications
Height SDS was calculated using the formula: SDS = (height - mean)/SD, where height was the height variable measured, mean and SD of height by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height and negative SDS indicated lesser height than the mean of the reference population. The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline height SDS as a covariate. Positive value in change from baseline indicated that SDS was better than baseline SDS. Missing values were imputed using the last observation carried forward (LOCF) method.
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
| Arm | Type | Description |
|---|---|---|
| 0.033 mg/kg/day | EXPERIMENTAL | - |
| 0.066 mg/kg/day | EXPERIMENTAL | - |
| hGH:12months treatment | EXPERIMENTAL | - |
| hGH: 6 month un-treatment + 6 month treatment | ACTIVE_COMPARATOR | - |
| Low dose 33 mcg/kg/day | EXPERIMENTAL | - |
| High dose 66 mcg/kg/day | EXPERIMENTAL | - |
| 0.033 mg / NN-220 | EXPERIMENTAL | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| 0.067 mg / NN-220 | EXPERIMENTAL | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| No treatment | NO_INTERVENTION | No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period |
| No treatment --> 0.033 mg | EXPERIMENTAL | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| No treatment --> 0.067 mg | EXPERIMENTAL | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Lyophilized | ACTIVE_COMPARATOR | - |
| Liquid | EXPERIMENTAL | - |
| Somatropin | EXPERIMENTAL | - |
| Low dose | EXPERIMENTAL | - |
| High dose | EXPERIMENTAL | - |
| Norditropin® | EXPERIMENTAL | - |
| Genotropin® | ACTIVE_COMPARATOR | - |
| ESRD patients | EXPERIMENTAL | - |
| Healthy subjects | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| somatropin | DRUG | Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks. |
| placebo | DRUG | - |
Inclusion Criteria: * Japanese children with Noonan syndrome clinically diagnosed in one of the following ways: 1. Clinically diagnosed by at least two medical experts using van der Burgt score list, 2. Clinically diagnosed by one medical expert using van der Burgt score list and diagnosed by resul...
Somatropin is an investigational small molecule being developed for conditions including bone fracture, chronic kidney disease, growth disorder, foetal growth problem, genetic disorder, and growth hormone disorder. It is being studied in the musculoskeletal therapeutic area. The drug is currently in Phase 2 clinical development.
Somatropin is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for various growth-related and musculoskeletal conditions.
Somatropin is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating conditions such as growth disorders and foetal growth problems.
Somatropin has been studied in nine clinical trials, all of which are completed. These include trials such as NCT00184691, NCT00184717, NCT00184756, and NCT00557336, which evaluated growth hormone treatment in children born small for gestational age. The trials were conducted in multiple countries including Spain, Japan, and others.
Somatropin is a form of growth hormone used in clinical trials for conditions like foetal growth problems and small for gestational age. The trials listed for somatropin are titled 'Growth Hormone Treatment' studies, indicating that somatropin is being investigated as a growth hormone therapy for children with growth issues.