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Pediatric Postoperative Analgesia Herniorrhaphy Study
Sponsor: Heron Therapeutics
Summary
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
Official title: A Phase 2, 2-Part, Open-Label, Dose-Finding and Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of HTX-011 for Postoperative Analgesia in Adolescents and Children (≥3 to <17 Years of Age) Undergoing Unilateral Open Inguinal Herniorrhaphy
Key Details
Gender
All
Age Range
3 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2023-07
Completion Date
2025-12
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
HTX-011
Dose to be determined from Cohort 1.
HTX-011
Dose to be determined from Cohorts 1 and 2.
HTX-011
Dose to be determined from Cohort 1 Part A.
Luer Lock Applicator
Applicator for instillation.