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Phase 2 Bunionectomy HTX-011 Administration Study

NCT03718039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-02

Study results available
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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

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.

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2019-01-31
Completion
2019-03-11
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 NCT03718039 on ClinicalTrials.gov