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Phase 2

Postherpetic Neuralgia | Unknown | Pain |DURECT Corporation|Last Updated: Sep 11, 2009

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 Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00478179Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic NeuralgiaPHASE2 COMPLETED 60Sep 1, 2006Dec 1, 2007Sep 11, 20097 United States
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Study Endpoints
Primary Endpoints
Reduction of pain with mean daily pain intensity
Secondary Endpoints
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Transdermal/Patch (Bupivacaine TTS [Eladur™])DRUG -
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Male or females age 21 years or older. * Pain in thoracic or lumbar regions for a minimum of 90 days after crusting of Herpes Zoster (HZ) lesions. * Stable prescribed medications regimen (including opioids, anticonvulsants, and tricyclic antidepressants). * Intact, unbroken sk...

Countries:United States
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