RecruitingPhase 3

A Study of TLC590 for Postsurgical Pain Following Bunionectomy

United States300 participantsStarted 2025-11-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able and willing to provide written informed consent.
✓. Male or female aged 18 years or older (inclusive).
✓. Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
✓. ASA Physical Status Classification of 1 or 2.
✓. Male subjects must be either biologically or surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence.
✓. Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, or committing to the use of a highly effective method of birth control.
✓. BMI \>18 \~ ≤39 kg/m2, with a minimum weight of 50 kg.

Exclusion criteria

✕. An abnormal clinical laboratory test value.
✕. Evidence of a clinically significant abnormal 12-lead ECG.
✕. History of orthostatic hypotension, syncope, or other syncopal attacks.
✕. History or any clinical manifestation of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that have been assessed by the Investigator to make the subject unsuitable for participation in the study.
✕. History of seizures or taking anticonvulsants.
✕. History of cardiac arrhythmia or taking Class III antiarrhythmic drugs.
✕. History of sleep apnea or at-home CPAP treatment.
✕. History of hypersensitivity to ropivacaine, bupivacaine, any other amide-type local anesthetic, or any other trial-required medications.

What they're measuring

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.

Timeframe: 72 hours

Trial details

NCT IDNCT07222748

SponsorTLC Biopharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Jack Chang

+886-2-26557377 Jack@tlcbio.com

View on ClinicalTrials.gov More Postoperative Pain trials