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Genotropin Somatropin

Phase 3

Infant, Small for Gestational Age | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Nov 4, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

Genotropin Somatropin · 1 trial · 1 indication

Phase 3 1
NCT00627523Genotropin Treatment In Very Young Children Born Small For Gestational AgeInfant, Small for Gestational Age
COMPLETED43 Analytics
PHASE3COMPLETED
Genotropin Treatment In Very Young Children Born Small For Gestational Age
Infant, Small for Gestational Age
NCT0062752343
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Study Endpoints

Primary Endpoints

Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.
Baseline and Month 24

Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.

Secondary Endpoints

Change From Baseline in Growth Velocity SDS at Month 24.
Baseline and Month 24
Change From Baseline in Height SDS at Month 12.
Baseline and Month 12
Change From Baseline in Growth Velocity SDS at Month 12.
Baseline and Month 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTALThe active treatment arm
ControlEXPERIMENTALControl

Interventions

NameTypeDescription
Genotropin (PN-180,307) SomatropinDRUGInjectable Genotropin
Control-no treatmentDRUGControl-no treatment
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Eligibility Criteria

Age Range19 Months to 29 Months
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: Caucasian male or female subjects aged between 19-29 months at Screening Visit 1. Born SGA (birth length and/or weight \<-2 SD for gestational age, using country-specific standards). Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length be...

Countries:BelgiumCzechiaFranceGermanyItalyNetherlandsSpainSwedenSwitzerland
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Frequently asked questions about Genotropin Somatropin

What is Genotropin Somatropin used for in Infant, Small for Gestational Age?

Genotropin Somatropin is used for the treatment of infants born small for gestational age. It is a small molecule therapy being developed by Pfizer, Inc. for this endocrine condition. The drug is currently in Phase 3 clinical development, with one completed trial involving 43 participants.

What does Genotropin Somatropin target?

Genotropin Somatropin is a recombinant human growth hormone that works by replacing or supplementing the body's natural growth hormone. It stimulates growth and cell reproduction in patients who are small for gestational age. The drug is being studied for its effects on growth outcomes in very young children.

Who makes Genotropin Somatropin?

Genotropin Somatropin is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research on this drug for the treatment of infants born small for gestational age.

What phase is Genotropin Somatropin in?

Genotropin Somatropin is in Phase 3 clinical development. The drug is investigational and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being studied for use in infants born small for gestational age.

What clinical trials is Genotropin Somatropin in?

Genotropin Somatropin has one completed Phase 3 clinical trial registered under NCT00627523, titled 'Genotropin Treatment In Very Young Children Born Small For Gestational Age.' This trial enrolled 43 participants across multiple European countries, including Belgium, France, Germany, Italy, and Spain.

Is Genotropin Somatropin the same as somatropin?

Genotropin Somatropin is a brand name for somatropin, which is a recombinant human growth hormone. The drug is being developed by Pfizer, Inc. for the treatment of infants born small for gestational age. It is currently in Phase 3 clinical development.