Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

NCT03485014 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 402-C-120
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• AUC of EXPAREL concentration

  Area under the concentration curve for EXPAREL

  0-96 hours

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events and serious adverse events

  0-30 days

Study Arms (1)

Experimental: EXPAREL 4 mg/kg

EXPERIMENTAL

Single dose of EXPAREL 4 mg/kg

Drug: Exparel

Interventions

Exparel DRUG

EXPAREL 4 mg/kg

Experimental: EXPAREL 4 mg/kg

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Robert T Ballock, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Igor Grachev, MD, PhD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: April 10, 2018
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: August 2, 2023

Record last verified: 2023-08

Locations

US (1)