Recent Updates
Recently added Catalysts

somatropine

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00476385Practicability and Acceptability of Stylomax® in ChildrenPHASE3 COMPLETED 12Jun 1, 2003 -Feb 12, 20091 France
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
practicability/acceptability of the Stylomax pen
at each visit
Secondary Endpoints
tolerability : pain (evaluation on pain scale)
at each visit
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range3 Years — 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
Unlock Eligibility Criteria