Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
WITHDRAWN
NCT03922048
PHASE2

Pediatric Postoperative Analgesia Herniorrhaphy Study

Sponsor: Heron Therapeutics

View on ClinicalTrials.gov

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

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.