๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-30

A Study of TLC590 for Postsurgical Pain Following Bunionectomy (NCT07222748)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: TLC Biopharmaceuticals, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Clinical Pharmacology of Miami โ€” Miami, Florida

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (4 Sites)

  • Clinical Pharmacology of Miami โ€” Miami, Florida
  • First Surgical Hospital โ€” Bellaire, Texas
  • Memorial Hermann Village โ€” Houston, Texas
  • Endeavor Clinical Trials โ€” San Antonio, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—