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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 a small molecule being studied for use in anorexia nervosa, specifically in children with the condition who also experience interruption of growth, delayed puberty, and osteopenia with failure of acquisition of bone mass. It is currently in Phase 2 clinical development and remains investigational.
Norditropine simplexx is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its effects on growth and bone mass in children with anorexia nervosa, based on its proposed role in addressing growth-related complications.
Norditropine simplexx is developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting clinical research on this drug for the treatment of anorexia nervosa in pediatric patients.
Norditropine simplexx is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.
Norditropine simplexx has been studied in one completed Phase 2 clinical trial, identified as NCT01626833. This trial enrolled 15 participants in France and evaluated the drug in children with anorexia nervosa, growth interruption, delayed puberty, and osteopenia. The trial was randomized, double-blind, and placebo-controlled.
Norditropine simplexx is a brand name associated with somatropine, a form of growth hormone. The drug is being developed by Novo Nordisk for anorexia nervosa. It is important to note that somatropine is a well-known hormone, but this specific formulation is under investigation for this indication.