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Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

Primary Purpose

Postoperative Pain Management

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exparel
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Management

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects whose parent(s) or guardian(s) has/have signed and dated an informed consent form for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
  2. American Society of Anesthesiologists (ASA) Class 1-3.
  3. Male or female subjects 12 to less than 17 years of age on the day of surgery.
  4. Body mass index (BMI) at screening within the 20th to 80th percentile for age and sex.
  5. A pregnancy test for female subjects of childbearing potential will be conducted in the preoperative holding area according to the study site's standard of care. A negative result for the pregnancy test must be available prior to the start of surgery.
  6. Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes in order to enable accurate and appropriate responses to study assessments, and provide informed consent/assent.
  7. Subjects must be able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

  1. Contraindication to bupivacaine or other amide-type local anesthetics or to opioid medication.
  2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
  3. Subjects with coagulopathies or immunodeficiency disorders.

  4. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

    In addition, the subject will be ineligible to receive study drug if the following criterion is met during surgery:

  5. Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: EXPAREL 4 mg/kg

Arm Description

Single dose of EXPAREL 4 mg/kg

Outcomes

Primary Outcome Measures

AUC of EXPAREL concentration
Area under the concentration curve for EXPAREL

Secondary Outcome Measures

Incidence of treatment-emergent adverse events and serious adverse events
Incidence of treatment-emergent adverse events and serious adverse events through 30 days

Full Information

First Posted
March 26, 2018
Last Updated
August 1, 2023
Sponsor
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03485014
Brief Title
Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
Official Title
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Local Administration of EXPAREL for Postsurgical Analgesia in Pediatric Subjects 12 to Less Than 17 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
February 12, 2019 (Actual)
Study Completion Date
February 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacira Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery. Secondary objective: The secondary objective of this study is to evaluate the safety of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
Detailed Description
This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXAPREL when administered intraoperatively at the end of surgery via local infiltration. Fifteen pediatric subjects 12 to less than 17 years of age undergoing spinal surgeries are planned for enrollment. Subjects will be screened within 30 days prior to study drug administration. During the screening visit, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation. Subjects will undergo their pre-planned spinal surgeries per the institution's standard of care. On Day 1, eligible subjects will receive a single dose of EXPAREL 4 mg/kg intraoperatively at the end of surgery via local infiltration into the surgical site. There is no required length of stay in the hospital; subjects may be discharged based on the medical judgment of the treating physician. A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit will be made on Day 30 to all subjects who received study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: EXPAREL 4 mg/kg
Arm Type
Experimental
Arm Description
Single dose of EXPAREL 4 mg/kg
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Description
EXPAREL 4 mg/kg
Primary Outcome Measure Information:
Title
AUC of EXPAREL concentration
Description
Area under the concentration curve for EXPAREL
Time Frame
0-96 hours
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events and serious adverse events
Description
Incidence of treatment-emergent adverse events and serious adverse events through 30 days
Time Frame
0-30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects whose parent(s) or guardian(s) has/have signed and dated an informed consent form for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable). American Society of Anesthesiologists (ASA) Class 1-3. Male or female subjects 12 to less than 17 years of age on the day of surgery. Body mass index (BMI) at screening within the 20th to 80th percentile for age and sex. A pregnancy test for female subjects of childbearing potential will be conducted in the preoperative holding area according to the study site's standard of care. A negative result for the pregnancy test must be available prior to the start of surgery. Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes in order to enable accurate and appropriate responses to study assessments, and provide informed consent/assent. Subjects must be able to adhere to the study visit schedule and complete all study assessments. Exclusion Criteria: Contraindication to bupivacaine or other amide-type local anesthetics or to opioid medication. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration. Subjects with coagulopathies or immunodeficiency disorders. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. In addition, the subject will be ineligible to receive study drug if the following criterion is met during surgery: Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Ballock, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Igor Grachev, MD, PhD
Organizational Affiliation
Pacira Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

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