Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SOMATROPINE
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 is being studied for anorexia nervosa, specifically in children with severe decrease of growth velocity. The Phase 2 trial also enrolled patients with interruption of growth, delayed puberty, and osteopenia with failure of acquisition of bone mass. It is not an approved treatment for these conditions and remains in clinical development.
Norditropine simplexx is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company sponsored the clinical research evaluating the drug in pediatric anorexia nervosa and related growth complications.
Norditropine simplexx is in Phase 2 development. The single registered trial, NCT01626833, has been completed, and no trials are currently active. The drug is investigational and is not approved for anorexia nervosa or any related growth condition.
Norditropine simplexx was evaluated in one 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, ages 8 years and older, and used a randomized, double-blind, placebo-controlled design.