At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 98 enrolled
Drug / intervention
Exparel +1 moredrug
Likely dose
Exparel 4mg/kgfrom 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 Multicenter Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less Than 17 Years
In Brief
A Phase 3 clinical trial evaluating Exparel and 0.5% Bupivacaine HCl for Postoperative Pain Management. Completed, enrolled 98 participants across 17 sites.
Detailed Summary
Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries. Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain Management
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartApr 2019
Primary CompletionAug 2019
Study CompletionSep 2019
TodayJul 2026
First PostedSep 24, 2018
Enrollment StartApr 2, 2019
Primary CompletionAug 30, 2019
Study CompletionSep 24, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.8 years ago
Interventions
Expareldrug
EXPAREL 4mg/kg (maximum 266 mg)
0.5% Bupivacaine HCldrug
Bupivacaine HCl 2mg/kg