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Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

NCT03682302 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-01-06

Study results available
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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.

Conditions

  • Postoperative Pain Management

Interventions

DRUG

Exparel

EXPAREL 4mg/kg (maximum 266 mg)

DRUG

0.5% Bupivacaine HCl

Bupivacaine HCl 2mg/kg

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Igor Grachev, MD, PhD · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2019-08-30
Completion
2019-09-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682302 on ClinicalTrials.gov