NCT02199574

Brief Summary

The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 29, 2016

Completed
Last Updated

March 8, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

July 23, 2014

Results QC Date

May 20, 2016

Last Update Submit

February 11, 2021

Conditions

Pain

Outcome Measures

Primary Outcomes (6)

  • Maximum Plasma Concentration (Cmax)

    From time of study drug administration through Day 7 postdose

  • Time to Maximum Plasma Concentration (Tmax)

    From time of study drug administration through Day 7 postdose

  • Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))

    From time of study drug administration through Day 7 postdose

  • Apparent Terminal Elimination Half-life

    From time of study drug administration through Day 7 postdose

  • Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))

    From time of study drug administration through Day 7 postdose

  • The Apparent Terminal Elimination Rate Constant (λz)

    From time of study drug administration through Day 7 postdose

Study Arms (1)

EXPAREL

EXPERIMENTAL

Single administration of EXPAREL 133 mg (10 mL).

Drug: EXPAREL

Interventions

EXPARELDRUG

133 mg EXPAREL in 10 mL.

Also known as: bupivacaine liposome injectable suspension
EXPAREL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, ≥18 years of age at the Screening Visit.
  • Subjects undergoing tonsillectomy with or without removal of the adenoids.
  • Able and willing to comply with all study visits and procedures.
  • Willing and capable of providing written informed consent.

You may not qualify if:

  • History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
  • Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure while participating in this study.
  • Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration. Female subjects must be surgically sterile, at least 2 years postmenopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before EXPAREL administration.
  • Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or procedures, or cause inability to comply with the study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Hermann - Memorial City Medical Center

Houston, Texas, 77024, United States

Location

Memorial Village Surgery Center

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pacira Medical Information
Organization
Pacira Pharmaceuticals, Inc.
MedInfo@pacira.com
1-855-793-9727

Study Officials

  • Harold Minkowitz, MD

    Herman Memorial Hospital, Houston TX

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 24, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

March 8, 2021

Results First Posted

June 29, 2016

Record last verified: 2021-02

Locations

US(2)