A Study of TLC590 for Postsurgical Pain Following Bunionectomy

Part of paid clinical trials in Miami, Florida.

Sponsor
TLC Biopharmaceuticals, Inc.
Study ID
NCT07222748
Phase
PHASE3
Status
Recruiting
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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TLC590 — DRUG
    TLC590 (Ropivacaine Extended-Release Injectable Suspension)
  • Liposomal Bupivacaine — DRUG
    Bupivacaine Liposome Injectable Suspension
  • Saline Placebo — DRUG
    Normal Saline 0.9%

Study Details

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.

Key Dates

Start date
Nov 17, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TLC590
  • Active Comparator: Liposomal Bupivacaine
  • Placebo Comparator: Saline Placebo

Primary Outcome Measure

Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Saline Placebo. [ Time Frame: 72 hours ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33172-
First Surgical HospitalBellaireTexas77401-
Memorial Hermann VillageHoustonTexas77043-
Endeavor Clinical TrialsSan AntonioTexas78240-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology of Miami· Miami, FLFirst Surgical Hospital· Bellaire, TXMemorial Hermann Village· Houston, TXEndeavor Clinical Trials· San Antonio, TX

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