Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

PHASE3CompletedINTERVENTIONAL
Enrollment

412

Participants

Timeline

Start Date

October 24, 2017

Primary Completion Date

January 8, 2018

Study Completion Date

March 13, 2018

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

Trial Locations (15)

21122

Chesapeake Research Group, LLC, Pasadena

36608

Springhill Medical Center, Mobile

75093

Plano Surgical Hospital, Plano

77004

Hermann Drive Surgical Hospital, Houston

77027

Westside Surgical Hospital, Houston

78229

Endeavor Clinical Trials, San Antonio

78501

Futuro Clinical Trials, LLC, McAllen

78705

Optimal Research , LLC, Austin

84123

EPIC Medical Research, LLC, Murray

84124

Jean Brown Research, Salt Lake City

85059

Arizona Research Center, Phoenix

85206

Orthopaedic Specialists of North America, PLLC, Mesa

92653

Alliance Research Centers, Laguna Hills

92801

Anaheim Clinical Trials, LLC, Anaheim

93301

Trovare Clinical Research, Inc., Bakersfield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Heron Therapeutics

INDUSTRY