NCT03922048

Pediatric Postoperative Analgesia Herniorrhaphy Study

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	HTX-011	Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
DRUG	Bupivacaine HCl	Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
DRUG	HTX-011	Dose to be determined from Cohort 1.
DRUG	HTX-011	Dose to be determined from Cohorts 1 and 2.
DRUG	HTX-011	Dose to be determined from Cohort 1 Part A.
DEVICE	Luer Lock Applicator	Applicator for instillation.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2019-04-19
• Last updated: 2023-06-05

Regulatory

• FDA-regulated drug study
• FDA-regulated device study