Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

July 31, 2017

Primary Completion Date

December 22, 2017

Study Completion Date

January 16, 2018

Conditions
Postoperative Pain
Interventions
DRUG

HTX-011

HTX 011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation

DRUG

Bupivacaine HCl

Bupivacaine HCl without epinephrine, 75 mg by injection

DRUG

Saline placebo

Saline placebo by instillation

DEVICE

Luer-lock applicator

Applicator for instillation

DEVICE

Vial access device

Device for withdrawal of drug product

Trial Locations (24)

3500

Jessa Ziekenhuis, Hasselt

3600

Ziekenhuis Oost Limburg, Genk

32750

Cornerstone Research Institute, LLC, Longwood

32751

Park Place Surgery Center, Maitland

33136

University of Miami, Miami

35630

Eliza Coffee Memorial Hospital, Florence

35660

Shoals Medical Trials, Inc., Sheffield

45417

Midwest Clinical Research, Dayton

63141

St. Louis Clinical Trials, St Louis

75093

Plano Surgical Hospital, Plano

77004

Hermann Drive Surgical Hospital, Houston

77027

Westside Surgical Hospital, Houston

78229

Endeavor Clinical Trials, P.A., San Antonio

84123

EPIC Medical Research, LLC, Murray

84124

Jean Brown Research, Salt Lake City

85053

Arizona Research Center, Phoenix

89109

eStudySite, Las Vegas

90603

American Institute of Research, Whittier

91105

Lotus Clinical Research, LLC, Pasadena

92503

HD Research Corp, Riverside

92653

Alliance Research Centers, Laguna Hills

92801

Anaheim Clinical Trials, LLC, Anaheim

93301

Trovare Clinical Research, Inc., Bakersfield

06511

Yale University School of Medicine, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Heron Therapeutics

INDUSTRY