Study Assessing Pain Relief After Replacement of the Knee

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

February 3, 2025

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Total Knee Arthroplasty (Postoperative Pain)
Interventions
DRUG

ATX101

ATX101 bupivacaine implants, total of 1,500 mg into the surgical site

DRUG

bupivacaine hydrochloride

bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration

DRUG

saline placebo

normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration

Trial Locations (11)

21122

Chesapeake Research Group, LLC, Pasadena

30331

Atlanta Centre for Medical Research, Atlanta

33321

Phoenix Clinical Research, Tamarac

67214

NextStage Clinical Research, Wichita

72211

Woodland International Research Group, LLC, Little Rock

75006

Legent Orthopedic Hospital, Carrollton

77043

Memorial Hermann Village, Houston

77401

First Surgical Hospital, Bellaire

78240

Endeavor Clinical Trials, LLC, San Antonio

78258

NextStage Clinical Research, San Antonio

84107

JBR Clinical Research, LLC, Salt Lake City

Sponsors
All Listed Sponsors
lead

Allay Therapeutics, Inc.

INDUSTRY