RecruitingPhase 3NCT07222748

A Study of TLC590 for Postsurgical Pain Following Bunionectomy

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


Sponsor

TLC Biopharmaceuticals, Inc.

Enrollment

300 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Liposomal Bupivacaine, a drug called Saline Placebo, and others for people with postoperative pain. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTLC590

TLC590 (Ropivacaine Extended-Release Injectable Suspension)

DRUGLiposomal Bupivacaine

Bupivacaine Liposome Injectable Suspension

DRUGSaline 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

View Full Details on ClinicalTrials.gov

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NCT07222748


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