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RECRUITING
NCT07222748
PHASE3

A Study of TLC590 for Postsurgical Pain Following Bunionectomy

Sponsor: TLC Biopharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.

Official title: A Phase 3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-11-17

Completion Date

2026-05

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

DRUG

TLC590

TLC590 (Ropivacaine Extended-Release Injectable Suspension)

DRUG

Liposomal Bupivacaine

Bupivacaine Liposome Injectable Suspension

DRUG

Saline Placebo

Normal Saline 0.9%

Locations (4)

Clinical Pharmacology of Miami

Miami, Florida, United States

First Surgical Hospital

Bellaire, Texas, United States

Memorial Hermann Village

Houston, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States