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Bupivacaine liposome

Phase 3

Dental Pain | Small molecule | Pain |Pacira BioSciences, Inc.|Last Updated: Dec 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment166

FDA Designations

No designations recorded

Clinical trial landscape

Bupivacaine liposome · 1 trial · 1 indication

Phase 3 1
NCT02517905Evaluation of EXPAREL for Prolonged Postsurgical Analgesia in Subjects Undergoing Third Molar ExtractionDental Pain
COMPLETED166 Analytics
PHASE3COMPLETED
Evaluation of EXPAREL for Prolonged Postsurgical Analgesia in Subjects Undergoing Third Molar Extraction
Dental PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve (AUC) of Numeric Rating Scale (NRS) Pain Intensity Scores Through 48 Hours
0-48 hours

AUC of NRS pain intensity scores through 48 hours. Pain intensity scores were measured on a 10-point scale (0=no pain and 10=worst possible pain)

Secondary Endpoints

Area Under the Curve (AUC) of Numeric Rating Scale (NRS) Pain Intensity Scores Through 24 Hours
0-24 hours
Area Under the Curve (AUC) of Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours
0-72 hours
Percentage of Opioid-free Subjects Through 24 Hours.
0-24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EXPAREL 133 mgEXPERIMENTAL10 mL EXPAREL (bupivacaine liposome injectable suspension) injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration
PlaceboPLACEBO_COMPARATOR10 mL normal saline injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration

Interventions

NameTypeDescription
Bupivacaine liposomeDRUGLocal administration
PlaceboDRUGLocal administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or female, ≥18 years of age at screening. 2. Scheduled to undergo bilateral third molar extractions (i.e., extraction of all four third molars) under local anesthesia. At least one lower mandibular third molar must involve full or partial bony impaction confirmed by visu...

Countries:United States
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Competitive Landscape -Dental and Oral Health 14 trials (matched to "Dental Pain")