At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 166 enrolled
Drug / intervention
Bupivacaine liposome +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Local Administration of EXPAREL for Prolonged Postsurgical Analgesia in Subjects Undergoing Third Molar Extraction
In Brief
A Phase 3 clinical trial evaluating Bupivacaine liposome and Placebo for Dental Pain. Completed, enrolled 166 participants across 1 site.
Detailed Summary
This is a Phase 3, randomized, double-blind, placebo-controlled study in subjects scheduled to undergo elective bilateral third molar extraction under local anesthesia. At least one lower mandibular third molar must involve full or partial bony impaction confirmed by visual or radiographic evidence.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesUnited States
CollaboratorsLotus Clinical Research, LLC
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedAug 2015
Primary CompletionJan 2016
TodayJul 2026
First PostedAug 7, 2015
Enrollment StartAug 1, 2015
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.9 years ago
Interventions
Bupivacaine liposomedrug
Local administration
Placebodrug
Local administration