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Ruboxistaurin

Phase 3

Diabetic Neuropathies | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Nov 6, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment600
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00044395Treatment for Symptomatic Peripheral Neuropathy in Patients With DiabetesPHASE3 COMPLETED 200 — — Jul 1, 2002Oct 1, 2005Nov 6, 200739 United States, Australia +7
NCT00044421Treatment of Peripheral Neuropathy in Patients With DiabetesPHASE3 COMPLETED 400 — — Jul 1, 2002Oct 1, 2006Nov 6, 200771 United States, Australia +13
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Study Endpoints
Primary Endpoints
Reduction in neuropathic symptoms
Reduction in the progression of DPN measured by composite score
Secondary Endpoints
Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change
Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Ruboxistaurin mesylateDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Patients must have type I or type II Diabetes Mellitus. * Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 month...

Countries:United StatesAustraliaBelgiumDenmarkEstoniaGermanyHungaryIsraelSpainCanadaCroatiaFinlandIndiaLithuaniaNetherlandsUnited Kingdom
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