๐๏ธ Verified NIH Record โข 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
๐ต Active, Not Recruiting Phase3 ๐ Investigational Drug / Biologic Sponsor: TLC Biopharmaceuticals, Inc.
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.