NCT07222748Active, not recruitingPhase 3
A Phase 3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
TLC Biopharmaceuticals, Inc.8 sites in 1 country304 target enrollmentStarted: November 17, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 304
- Locations
- 8
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
- •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.
- •Use of daily analgesics for longer than 4 days per week for a chronically painful condition.
- •Is receiving oxygen therapy.
- •Use of any of the pre-specified medications prior to the study surgical procedure or as specified.
- •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.
- •Personal or family history of malignant hyperthermia.
Arms & Interventions
Saline Placebo
Placebo Comparator
Intervention: Saline Placebo (Drug)
TLC590
Experimental
Intervention: TLC590 (Drug)
Liposomal Bupivacaine
Active Comparator
Intervention: Liposomal Bupivacaine (Drug)
Outcomes
Primary Outcomes
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
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.
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
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.
Secondary Outcomes
- 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)
- 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)
Investigators
Study Sites (8)
Loading locations...
Similar Trials
Completed
Phase 3
A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell CarcinomaNCT03957590BeiGene370
Completed
Phase 3
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic DermatitisAtopic DermatitisNCT03796676Pfizer287
Recruiting
Phase 3
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)Psychosis Associated With Alzheimer's DiseaseNCT06126224Karuna Therapeutics, Inc., a Bristol Myers Squibb company500
Recruiting
Phase 3
A study to compare the effectiveness and safety of Atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal functionCTRI/2022/06/043396Chinook Therapeutics320
Active, not recruiting
Phase 3
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein CholesterolCTRI/2012/09/003013Genzyme India480