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somatropin

Phase 3

Fetal Growth Retardation | Small molecule | Other |Sanofi|Last Updated: Oct 5, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment306

FDA Designations

No designations recorded

Clinical trial landscape

somatropin · 1 trial · 1 indication

Phase 3 1
NCT00452491MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal ChildrenFetal Growth Retardation
COMPLETED306 Analytics
PHASE3COMPLETED
MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children
Fetal Growth RetardationUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy data : measurement of height
at trimestrial visit

Secondary Endpoints

laboratory test assessment and evaluation of bone age
at every other visit
measurement of anti-GH and anti-ECP antibodies
one visit out of four
Tolerance data : undesirable events
throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
somatropinDRUG0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years
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Eligibility Criteria

Age Range3 Years to 11 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.) * Height Less Than or Equal to -3 SD Exclusion Criteria: * Age less than 3 years The above information is not intended to contain all considerations relevant to...

Countries:France
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Frequently asked questions about somatropin

What is somatropin used for?

Somatropin is used for fetal growth retardation, specifically in the treatment of severe early onset intrauterine growth retardation in pre-pubertal children. It is being investigated as a treatment for this condition in a clinical trial setting.

Who makes somatropin?

Somatropin is being developed by Sanofi, a biopharmaceutical company. Sanofi is conducting clinical trials to evaluate the drug's efficacy and safety in treating fetal growth retardation.

What phase is somatropin in?

Somatropin is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved for use and is still being studied in clinical trials to assess its safety and effectiveness.

What clinical trials is somatropin in?

Somatropin is being studied in a Phase 3 clinical trial with the identifier NCT00452491. This trial is titled 'MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children' and has been completed.

What is the trial for somatropin studying?

The clinical trial for somatropin is studying its use in treating fetal growth retardation in pre-pubertal children. The trial enrolled 306 participants in France, with a minimum age of 3 years, and included both males and females.