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Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

NCT03295721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-03-02

Study results available
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Summary

This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.

Conditions

  • Postoperative Pain

Interventions

DRUG

HTX-011

HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation

DRUG

Saline Placebo

Saline placebo by instillation

DRUG

Bupivacaine HCl

Bupivacaine HCl without epinephrine, 50 mg by injection

DEVICE

Luer-lock applicator

Applicator for instillation

DEVICE

Vial access device

Device for withdrawal of drug product

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
2017-10-24
Primary Completion
2018-01-08
Completion
2018-03-13
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 NCT03295721 on ClinicalTrials.gov