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GW493838

Phase 2

Neuropathic Pain | Small molecule | Neurology |GSK plc|Last Updated: Feb 12, 2013

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment113
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00376454The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic PainPHASE2 COMPLETED 113Nov 1, 2002Jun 1, 2003Feb 12, 201332 United States
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Study Endpoints
Primary Endpoints
Pain intensity
Secondary Endpoints
Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GW493838DRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion criteria (subjects must meet all of the following criteria in order to be eligible for this study): * Females of non-child-bearing potential * diagnosis of peripheral neuropathic pain as a result of: postherpetic neuralgia (PHN) from shingles for at least 3 months duration OR focal neurop...

Countries:United States
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