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A Study of TLC590 for Postsurgical Pain Following Bunionectomy

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv3 Show 4 more changesShow less
    • Enrollment target: estimated 300 to confirmed 304
    • Primary completion date changed from estimate of Apr 2026 to Jun 12, 2026
    • Study completion date: May 2026 to Jul 2026
    • Site details revised at 4 of 4 sites
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 2 to 4
    • Start date changed from estimate of Nov 2025 to Nov 17, 2025
    • Interventions: Bupivacaine (Drug), Saline Placebo (Drug), TLC590 (Drug) to Liposomal Bupivacaine (Drug), Saline Placebo (Drug), TLC590 (Drug)
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study title shortened, about 3 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07222748
Lead Sponsor TLC Biopharmaceuticals, Inc.
Conditions
(from sponsor)		 Postoperative Pain
Related terms Bunion, Postoperative Pain
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov