A Multicenter Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less Than 17 Years

Pacira Pharmaceuticals, Inc17 个研究点分布在 1 个国家目标入组 98 人开始时间: 2019年4月2日最近更新: 2021年1月6日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Pacira Pharmaceuticals, Inc
入组人数: 98
试验地点: 17
主要终点: Maximum Plasma Concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

This is a Phase 3, two-part, multi-center, open-label study designed to evaluate the PK and safety profile of EXPAREL in pediatric subjects aged 6 to less than 17 years when administered intraoperatively at the end of surgery via local infiltration. 90 pediatric subjects undergoing spine and/or cardiac surgeries are planned for enrollment.

Part 1 is a multicenter, randomized, open-label study in subjects aged 6 to less than 17 years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1 will include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged 6 to less than 12 years

Part 2 is a multicenter, randomized, open-label, safety study in subjects aged 6 to less than 17 years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1 will include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged 6 to less than 12 years.

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 or cardiac surgeries per the institution's standard of care. On Day 1, eligible subjects will receive the study drug intraoperatively at the end of surgery via local infiltration into the surgical site. Dosing of EXPAREL will be based on body weight, with a starting dose of 4 mg/kg (maximum 266 mg).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 6 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF 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-
•Male or female subjects 6 to less than 17 years of age on the day of surgery.
•Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex (see Appendix 5).
•A negative pregnancy test for female subjects of childbearing potential must be available prior to the start of surgery. The pregnancy test must be conducted in the preoperative holding area according to the study site's standard of care.
•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 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.

排除标准

•Currently pregnant, breastfeeding, or planning to become pregnant during the study or within 1 month after study drug administration.
•History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
•Contraindication to bupivacaine HCl 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.
•History of, suspected, or known addiction to or abuse of drugs or alcohol within the past 2 years.
•Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.
•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 he or she meets the following criterion during surgery:
•Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.

研究组 & 干预措施

Group 1: 12 to less than 17 years, undergoing spine surgery, EXPAREL

Experimental

Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

干预措施: Exparel (Drug)

Group 1: 12 to less than 17 years, undergoing spine surgery, bupivacine

Active Comparator

Single dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.

干预措施: 0.5% Bupivacaine HCl (Drug)

Group 2: 6 to less than 12 years, undergoing spine surgery, EXPAREL

Experimental

Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

干预措施: Exparel (Drug)

Group 2: 6 to less than 12 years, undergoing cardiac surgery, EXPAREL

Experimental

Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.

干预措施: Exparel (Drug)