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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Liposome bupivacaine+ bupivacaine · 1 trial · 1 indication

Phase 2 1
NCT03106519Liposome Bupivacaine for WRIST BlocksDupuytren's Contracture of the Hand (Viking's Disease)
COMPLETED32 Analytics
PHASE2COMPLETED
Liposome Bupivacaine for WRIST Blocks
Dupuytren's Contracture of the Hand (Viking's Disease)Unlock trial analytics

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 to 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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Frequently asked questions about Liposome bupivacaine+ bupivacaine

What is Liposome bupivacaine used for?

Liposome bupivacaine is an investigational drug being studied for use in Hallux Valgus (Bunions) and Dupuytren's Contracture of the Hand (Viking's Disease). It is a small molecule being developed by Pacira BioSciences, Inc. for these indications.

What does Liposome bupivacaine target?

Liposome bupivacaine is a small molecule. Its specific molecular target has not been disclosed in the available information.

Who makes Liposome bupivacaine?

Liposome bupivacaine is being developed by Pacira BioSciences, Inc., a company traded under the ticker symbol PCRX.

What phase is Liposome bupivacaine in?

Liposome bupivacaine is in Phase 2 clinical development. It is investigational and has not been approved by regulatory authorities.

What clinical trials is Liposome bupivacaine in?

Liposome bupivacaine has been studied in two completed Phase 2 trials. NCT03106519 evaluated it for Dupuytren's Contracture of the Hand, and NCT03106545 evaluated it for Hallux Valgus (Bunions). Both trials were conducted in Belgium.

Is Liposome bupivacaine the same as bupivacaine?

Liposome bupivacaine is a formulation of bupivacaine, but it is not the same as standard bupivacaine. The liposome formulation is designed to provide extended release of the drug.