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GS856553

Phase 2

Pain, Neuropathic | Small molecule | Neurology |GSK plc|Last Updated: Jun 8, 2017

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment142
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01110057Efficacy Study in Lumbosacral RadiculopathyPHASE2 COMPLETED 142Jan 7, 2010Aug 23, 2010Jun 8, 201717 Denmark, France +3
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Study Endpoints
Primary Endpoints
Change in average daily neuropathic pain score from Baseline up to Week 5 (Week 4 of double blind treatment) of treatment
Baseline (Day -7 to Day -1) and up to 5 weeks

The scores were analyzed based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) with 0 score indicating no pain and score of 10 indicating maximum pain. The adjusted mean values are represented as least square mean (LS mean) values.

Secondary Endpoints
Change in average daily pain intensity rating score (PI-NRS) from Baseline (Day -7 to Day -1) to 5 Weeks
Baseline (Day -7 to Day -1) and up to 5 weeks
Change in pain quality on the Short-Form McGill Pain Questionnaire (SF-MPQ) from Baseline up to 5 weeks.
Baseline (Day -7 to Day -1) and up to 5 weeks
Number of participants with intensities of pain by SF-MPQ method over 5 weeks
From Baseline (Day -7 to Day -1) up to 5 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALGW856553
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
PlaceboDRUGPlacebo to match GW856553
GS856553DRUGGW586553 7.5mg bid
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites17

Key Inclusion Criteria: * Male or female subjects aged 18 - 80 years inclusive, at the time of signing the informed consent. * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or...

Countries:DenmarkFranceGermanyNorwaySweden
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