Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SOMATROPINE* : Norditropine® simplexx®
SOMATROPINE*: Norditropine simplexx · 1 trial · 4 indications
the growth velocity will be evaluated 1 year after the start of the trial (cm/1an) compared between the group with the placebo and hGH
| Arm | Type | Description |
|---|---|---|
| SOMATROPINE* : Norditropine® simplexx® | ACTIVE_COMPARATOR | SOMATROPINE\* : Norditropine® simplexx® |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SOMATROPINE* : Norditropine® simplexx® | DRUG | SOMATROPINE\* : Norditropine® simplexx® - 15 mg/1,5 ml, injectable solution:Treatment with hGH is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of hGH treatment will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist. |
| Placebo | BIOLOGICAL | Treatment with placebo is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of placebo will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist. |
Inclusion Criteria: * Medical screening. * Female and male subjects aged 8-16 years and 11 months, with clinical anorexia nervosa and / or reference to the diagnostic criteria of DSM-IV (1) before or at early puberty (Tanner stage 1 or 2) and with a prolonged Catch-Down for at least 18 months (HV ≤...
Norditropine simplexx has been studied in anorexia nervosa, specifically in children with severe decrease of growth velocity. The Phase 2 trial enrolled children with anorexia nervosa along with interruption of growth, delayed puberty, and osteopenia with failure of acquisition of bone mass. It is not an approved treatment for anorexia nervosa.
Norditropine simplexx is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the company behind the drug's clinical development in anorexia nervosa.
Norditropine simplexx is in Phase 2 development. The single recorded trial, NCT01626833, is a completed Phase 2 study, and no active trials are currently listed. It is an investigational product and is not approved for anorexia nervosa.
Norditropine simplexx was evaluated in the Phase 2 trial NCT01626833, titled Severe Decrease of Growth Velocity in Children With Anorexia Nervosa: Therapeutic Trial of Growth Hormone. The completed study enrolled 15 participants in France, was randomized, double blind, and placebo controlled, and included children aged 8 years and older.