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PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery

NCT02985762 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-04-10

No results posted yet for this study

Summary

The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery.

The secondary objectives of this study are to assess the safety, tolerability, and efficacy of EXPAREL in this surgical model.

Conditions

  • Spinal Fusion
  • Pain Management

Interventions

DRUG

EXPAREL

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Hassan Danesi, MD · Pacira Pharmaceuticals, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-09-30
Completion
2017-09-30

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 NCT02985762 on ClinicalTrials.gov