Actively Recruiting
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
Led by TLC Biopharmaceuticals, Inc. · Updated on 2025-12-02
300
Participants Needed
4
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Male or female aged 18 years or older (inclusive)
- Scheduled for 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 biologically or surgically sterile, use reliable birth control with double-barrier contraception, or practice abstinence
- Female subjects must not be pregnant, not lactating, not planning pregnancy during the study, or use highly effective birth control
- Body mass index between over 18 and up to 39 kg/m2 with a minimum weight of 50 kg
You will not qualify if you...
- Abnormal clinical laboratory test values
- Clinically significant abnormal 12-lead ECG
- History of orthostatic hypotension, syncope, or other fainting attacks
- Significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other conditions making participation unsuitable
- History of seizures or use of anticonvulsants
- History of cardiac arrhythmia or use of Class III antiarrhythmic drugs
- History of sleep apnea or use of at-home CPAP treatment
- Hypersensitivity to ropivacaine, bupivacaine, other amide-type local anesthetics, or required study medications
- Severe or refractory postoperative nausea and vomiting due to other causes
- Any history of suicidal attempt or behavior
- History or positive test for HIV, hepatitis C, or hepatitis B
- History or current substance or alcohol abuse
- Positive urine drug screen or alcohol breath test
- Acute or chronic painful conditions that may affect pain assessments or require analgesics during the study
- Known or suspected daily opioid use longer than 4 days/week within 6 months
- Use of daily analgesics longer than 4 days/week for chronic pain
- Receiving oxygen therapy
- Use of certain medications before surgery as specified
- Malignancy in past 2 years except some skin or cervical cancers
- Personal or family history of malignant hyperthermia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33172
Not Yet Recruiting
2
First Surgical Hospital
Bellaire, Texas, United States, 77401
Actively Recruiting
3
Memorial Hermann Village
Houston, Texas, United States, 77043
Actively Recruiting
4
Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Not Yet Recruiting
Research Team
J
Jack Chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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