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Liposome bupivacaine + bupivacaine

Phase 2

Dupuytren's Contracture of the Hand (Viking's Disease) | Small molecule | Other |Pacira BioSciences, Inc.|Last Updated: Sep 10, 2020

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03106519Liposome Bupivacaine for WRIST BlocksPHASE2 COMPLETED 32Jan 2, 2017Oct 31, 2017Sep 10, 20201 Belgium
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Study Endpoints
Primary Endpoints
Change in current pain over the first postoperative week
From baseline (before nerve block) through first postoperative week

Pain rating (NRS) at rest and with movement

Secondary Endpoints
Change in worst pain over the first postoperative week
From discharge from hospital through first postoperative week
Change in ability to use hand
From discharge from hospital through first postoperative week
Change in sleep quality
From discharge from hospital through first postoperative week
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single mixture LB & bupivacaineEXPERIMENTALA single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the median and ulnar nerves
Bupivacaine aloneACTIVE_COMPARATORBupivacaine 0.5% (7.5 mL) injected into the median and ulnar nerves
Interventions
NameTypeDescription
Liposome bupivacaine + bupivacaineDRUG -
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, at least 18 years and max 85 years of age at screening * Scheduled to undergo Dupuytren's contracture release * American Society of Anesthesiologists (ASA) physical status I, II or III * Able to demonstrate sensory function by exhibiting sensitivity to cold, pi...

Countries:Belgium
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