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somatropine

Phase 3

Growth Hormone Deficiency | Small molecule | Endocrine |Sanofi|Last Updated: Feb 12, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

somatropine · 1 trial · 1 indication

Phase 3 1
NCT00476385Practicability and Acceptability of Stylomax® in ChildrenGrowth Hormone Deficiency
COMPLETED12 Analytics
PHASE3COMPLETED
Practicability and Acceptability of Stylomax® in Children
Growth Hormone DeficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

practicability/acceptability of the Stylomax pen
at each visit

Secondary Endpoints

tolerability : pain (evaluation on pain scale)
at each visit
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
somatropineEXPERIMENTAL -

Interventions

NameTypeDescription
somatropineDRUGsubcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg
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Eligibility Criteria

Age Range3 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children over 3 years of age with growth hormone deficiency, requiring treatment with MAXOMAT® according to the criteria of the MA. Exclusion Criteria: * The above information is not intended to contain all considerations relevant to a patient's potential participation in a ...

Countries:France
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Frequently asked questions about somatropine

What is somatropine used for?

Somatropine is used for growth hormone deficiency. It is being developed by Sanofi as a small molecule for the endocrine condition. The drug is currently in Phase 3 clinical development, though it remains investigational and is not yet approved.

Who makes somatropine?

Sanofi (ticker: SNY) is developing somatropine. The company is conducting clinical trials for the drug, which is intended to treat growth hormone deficiency. Somatropine is in Phase 3 development.

What phase is somatropine in?

Somatropine is in Phase 3 clinical development. It is an investigational drug for growth hormone deficiency and has not been approved. One Phase 3 trial has been completed, involving 12 participants.

What clinical trials is somatropine in?

Somatropine has one completed Phase 3 trial, NCT00476385, titled 'Practicability and Acceptability of Stylomax® in Children'. The study enrolled 12 participants with growth hormone deficiency in France, with a minimum age of 3 years. It was an uncontrolled, non-randomized trial.

Is somatropine the same as Stylomax?

Yes, somatropine is associated with the brand name Stylomax, as indicated by the clinical trial title 'Practicability and Acceptability of Stylomax® in Children'. The trial evaluates somatropine for growth hormone deficiency.