A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 5, 2019

Primary Completion Date

March 31, 2020

Study Completion Date

March 31, 2020

Conditions
Hallux Valgus
Interventions
DRUG

TLC590

TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients

DRUG

Naropin®

Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)

DRUG

Normal Saline

Normal Saline (0.9% sodium chloride, 10ml)

DRUG

Bupivacaine

Bupivacaine 50 mg (0.5%, 10 mL)

Trial Locations (5)

78229

Endeavor Clinical Trials, San Antonio

84020

JBR clinical research, Draper

85053

Arizona Research Center, Phoenix

92801

Anaheim Clinical Trials, LLC, Anaheim

21122-1020

Chesapeake Research Group, Pasadena

Sponsors
All Listed Sponsors
lead

Taiwan Liposome Company

INDUSTRY