A Study of TLC590 for Postsurgical Pain Following Bunionectomy

NCT07222748 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: TLC590A3004
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Postoperative Pain

Keywords

Bunion; Bunionectomy; Bunion surgery; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.

  72 hours

Secondary Outcomes (5)

• Proportion of subjects who are opioid-free for TLC590 compared with Saline Placebo.

  72 hours

• Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Bupivacaine Liposome.

  72 hours

• Mean Total Postoperative Opioid Consumption for TLC590 Compared with Saline Placebo

  72 hours

• Proportion of subjects who are opioid-free for TLC590 compared with Bupivacaine Liposome.

  72 hours

• Mean Total Postoperative Opioid Consumption for TLC590 Compared with Bupivacaine Liposome.

  72 hours

Study Arms (3)

TLC590

EXPERIMENTAL

Drug: TLC590

Liposomal Bupivacaine

ACTIVE COMPARATOR

Drug: Liposomal Bupivacaine

Saline Placebo

PLACEBO COMPARATOR

Drug: Saline Placebo

Interventions

TLC590 DRUG

TLC590 (Ropivacaine Extended-Release Injectable Suspension)

TLC590

Liposomal Bupivacaine DRUG

Bupivacaine Liposome Injectable Suspension

Liposomal Bupivacaine

Saline Placebo DRUG

Normal Saline 0.9%

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of severe or refractory PONV due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer, deemed clinically significant by the Investigator.
• Any lifetime history of a suicidal attempt or any suicidal behavior.
• History or positive test results of HIV, HCV, or HBV.
• History or current report of substance abuse including illicit drug abuse and/or alcohol abuse.
• Positive results on the urine drug screen or alcohol breath test.
• Pre-existing concurrent acute, or chronic painful restrictive/physical condition that may confound postoperative pain assessments or is expected to require analgesic treatment during the study.
• Has known or suspected daily use of opioids for longer than 4 days per week within 6 months.

Sponsors & Collaborators

• TLC Biopharmaceuticals, Inc.: lead

Study Sites (4)

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

NOT YET RECRUITING

First Surgical Hospital

Bellaire, Texas, 77401, United States

RECRUITING

Memorial Hermann Village

Houston, Texas, 77043, United States

RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Bunion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Study Officials

• Tien-Tzu Tai, MD

  Taiwan Liposome Company

  STUDY DIRECTOR

Central Study Contacts

Jack Chang

CONTACT

+886-2-26557377; Jack@tlcbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 30, 2025
• Study Start: November 17, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (4)