226
Participants
Start Date
February 3, 2025
Primary Completion Date
October 31, 2025
Study Completion Date
October 31, 2025
ATX101
ATX101 bupivacaine implants, total of 1,500 mg into the surgical site
bupivacaine hydrochloride
bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration
saline placebo
normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration
Chesapeake Research Group, LLC, Pasadena
Atlanta Centre for Medical Research, Atlanta
Phoenix Clinical Research, Tamarac
NextStage Clinical Research, Wichita
Woodland International Research Group, LLC, Little Rock
Legent Orthopedic Hospital, Carrollton
Memorial Hermann Village, Houston
First Surgical Hospital, Bellaire
Endeavor Clinical Trials, LLC, San Antonio
NextStage Clinical Research, San Antonio
JBR Clinical Research, LLC, Salt Lake City
Lead Sponsor
Allay Therapeutics, Inc.
INDUSTRY