NCT03485014

Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 12 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Pain Management

Interventions

Type	Name	Description
DRUG	Exparel	EXPAREL 4 mg/kg

Timeline

• Start date: 2018-04-10
• Primary completion: 2019-02-12
• Completion: 2019-02-12
• First posted: 2018-04-02
• Last updated: 2023-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study