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drugset / Trial / NCT03485014

Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

NCT03485014 ↗

Phase 1 Completed 15 enrolled Pacira Pharmaceuticals, Inc
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-04-10
Primary completion
2019-02-12
Completion
2019-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 4 mg/kg Other

Indications

No indication recorded.