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somatropin, rDNA origin,

Phase 3

Growth Disorder | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 9, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00191074Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short StaturePHASE3 COMPLETED 11Feb 1, 2001Jan 1, 2006Mar 9, 20071 United States
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Study Endpoints
Primary Endpoints
Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
laboratory blood draws.
Secondary Endpoints
Not applicable for Amendment (g).
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
somatropin, rDNA origin, for injectionDRUG -
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Eligibility Criteria
Age Range9 Years — 16 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Participation in core, blinded phase and ability to be contacted by investigators. For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to disco...

Countries:United States
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Competitive Landscape -Growth Disorders 4 trials