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Xylocaine

Phase 1

Morton's Neuroma | Small molecule | Other |AstraZeneca PLC|Last Updated: May 22, 2012

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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01298310A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)EARLY_PHASE1 COMPLETED 27 — — Feb 1, 2011May 1, 2012May 22, 20121 Sweden
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Study Endpoints
Primary Endpoints
The baseline phenotypic Quantitative sensory testing (QST) variables (e.g. heat, cold, touch and mechanical pain perception). Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C)
Before and after drug injection at Day 1
The effect of Xylocaine compared to placebo in QST variables. Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C)
After drug injection at Day 1.
Secondary Endpoints
Frequency/severity of adverse events
Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Xylocaine_1mgACTIVE_COMPARATOR1 injection of Xylocaine (1 mg/mL)
Xylocaine_10mgACTIVE_COMPARATOR1 injection of Xylocaine (10 mg/mL)
PlaceboPLACEBO_COMPARATOR1 injection of placebo
Interventions
NameTypeDescription
XylocaineDRUG1 mg/mL solution for injection
PlaceboDRUGsolution for injection
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with a clinical diagnosis of Morton's neuroma with symptoms of at least 3 months duration in one foot (affected foot) * Visual analogue scale (VAS) pain-score of = 40 mm in the painful foot at daily activities during the previous week (visit 1) Exclusion Criteria: *...

Countries:Sweden
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