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A Study of TLC590 for Postsurgical Pain Following Bunionectomy

NCT07222748 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

TLC590

TLC590 (Ropivacaine Extended-Release Injectable Suspension)

DRUG

Liposomal Bupivacaine

Bupivacaine Liposome Injectable Suspension

DRUG

Saline Placebo

Normal Saline 0.9%

Sponsors & Collaborators

  • TLC Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Tien-Tzu Tai, MD · Taiwan Liposome Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-04-30
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222748 on ClinicalTrials.gov