MedTrace Logo

Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen

NCT03974932 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-03-02

Study results available
· View outcomes & findings →

Summary

Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.

Conditions

  • Analgesia

Interventions

DRUG

HTX-011

Dual-acting local anesthetic. Dose 1.

DRUG

Ibuprofen

NSAID.

DRUG

Acetaminophen

Analgesic.

DRUG

Celecoxib

NSAID.

DRUG

+/- Bupivacaine HCl

Local anesthetic.

DEVICE

Luer Lock Applicator

Applicator for instillation.

DRUG

HTX-011

Dual-acting local anesthetic. Dose 2.

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2020-12-07
Completion
2021-01-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03974932 on ClinicalTrials.gov