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Dose-Escalation Study of HTX-034 Following Bunionectomy

NCT04398329 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-06-09

Study results available
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Summary

This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.

Conditions

  • Bunions
  • Postoperative Pain

Interventions

DRUG

HTX-034 high dose

HTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg

DEVICE

Luer lock applicator

Applicator for instillation

DRUG

Bupivacaine HCl

Bupivacaine HCl 50 mg

DRUG

HTX-034 low dose

HTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2021-07-15
Completion
2021-07-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398329 on ClinicalTrials.gov