A Study of TLC590 for Postsurgical Pain Following Bunionectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

NCT03838133

Hallux Valgus

COMPLETED PHASE2

Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

NCT02762929

Postoperative Pain Bunions

COMPLETED PHASE2

Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

NCT03295721

Postoperative Pain

COMPLETED PHASE3

A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy

NCT02077140

Postoperative Pain

COMPLETED PHASE2

Evaluation of N1539 Following Bunionectomy Surgery

NCT02675907

Pain, Post-operative

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TLC590

Group Type EXPERIMENTAL

TLC590

Intervention Type DRUG

TLC590 (Ropivacaine Extended-Release Injectable Suspension)

Liposomal Bupivacaine

Group Type ACTIVE_COMPARATOR

Liposomal Bupivacaine

Intervention Type DRUG

Bupivacaine Liposome Injectable Suspension

Saline Placebo

Group Type PLACEBO_COMPARATOR

Saline Placebo

Intervention Type DRUG

Normal Saline 0.9%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TLC590

TLC590 (Ropivacaine Extended-Release Injectable Suspension)

Intervention Type DRUG

Liposomal Bupivacaine

Bupivacaine Liposome Injectable Suspension

Intervention Type DRUG

Saline Placebo

Normal Saline 0.9%

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Able and willing to provide written informed consent.
2. Male or female aged 18 years or older (inclusive).
3. Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
4. ASA Physical Status Classification of 1 or 2.
5. 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.
6. 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.
7. BMI \>18 \~ ≤39 kg/m2, with a minimum weight of 50 kg.

Exclusion Criteria

1. An abnormal clinical laboratory test value.
2. Evidence of a clinically significant abnormal 12-lead ECG.
3. History of orthostatic hypotension, syncope, or other syncopal attacks.
4. 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.
5. History of seizures or taking anticonvulsants.
6. History of cardiac arrhythmia or taking Class III antiarrhythmic drugs.
7. History of sleep apnea or at-home CPAP treatment.
8. History of hypersensitivity to ropivacaine, bupivacaine, any other amide-type local anesthetic, or any other trial-required medications.
9. 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.
10. Any lifetime history of a suicidal attempt or any suicidal behavior.
11. History or positive test results of HIV, HCV, or HBV.
12. History or current report of substance abuse including illicit drug abuse and/or alcohol abuse.
13. Positive results on the urine drug screen or alcohol breath test.
14. 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.
15. Has known or suspected daily use of opioids for longer than 4 days per week within 6 months.
16. Use of daily analgesics for longer than 4 days per week for a chronically painful condition.
17. Is receiving oxygen therapy.
18. Use of any of the pre-specified medications prior to the study surgical procedure or as specified.
19. Malignancy in the past 2 years, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
20. Personal or family history of malignant hyperthermia.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No