NCT03718039

Phase 2 Bunionectomy HTX-011 Administration Study

A Phase 2 Open-Label Study of HTX-011 Via Individualized Dosing Administration for Postoperative Analgesia Following Unilateral Simple Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	HTX-011	HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.
DEVICE	Luer Lock applicator	Applicator for instillation.
DEVICE	Vial access device	Device for withdrawal of drug product.
DRUG	aprepitant	Aprepitant, three single doses of aprepitant will be administered orally.

Timeline

• Start date: 2018-10-24
• Primary completion: 2019-01-31
• Completion: 2019-03-11
• First posted: 2018-10-24
• Last updated: 2026-03-02
• Results posted: 2023-06-26

Locations

1 site across 1 country: United States

Regulatory

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