Actively Recruiting
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
Led by TLC Biopharmaceuticals, Inc. · Updated on 2025-12-02
300
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 3, randomized, double-blind study to evaluate the pain relief and safety of TLC590 in adults after bunionectomy surgery. The study compares TLC590 with liposomal bupivacaine and a saline placebo to assess their effects on postoperative pain management. This research is sponsored by TLC Biopharmaceuticals, Inc. and focuses on pain following a specific foot surgery called bunionectomy. Participants will receive one of three treatments: TLC590 (a ropivacaine extended-release injectable suspension), liposomal bupivacaine, or a saline placebo. These treatments will be given by local infiltration during the surgery. The study aims to monitor pain relief and opioid use during the first 72 hours after surgery to compare the effects of these treatments. During the trial, participants will have their pain intensity measured using the Numeric Rating Scale over 72 hours after surgery. Researchers will also track opioid use and other safety measures. The study involves random assignment to treatment groups and triple masking to ensure unbiased results. The total participation duration includes the immediate 72-hour postoperative period with ongoing safety assessments.
CONDITIONS
Brief 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.
- Scheduled for 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 sterile or agree to use reliable birth control or abstain from sexual activity.
- Female subjects must not be pregnant, lactating, or planning pregnancy, or agree to use highly effective birth control.
- Body mass index between greater than 18 and 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 syncopal attacks.
- Significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other conditions unsuitable for study participation.
- 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, amide-type local anesthetics, or study medications.
- Severe or refractory postoperative nausea and vomiting from other causes.
- History of suicidal attempt or behavior.
- History or positive test for HIV, HCV, or HBV.
- History or current substance or alcohol abuse.
- Positive urine drug or alcohol breath test.
- Pre-existing acute or chronic painful conditions that may affect pain assessments.
- Daily opioid use over 4 days per week within 6 months.
- Daily analgesic use over 4 days per week for chronic pain.
- Receiving oxygen therapy.
- Use of pre-specified medications before surgery as defined.
- Malignancy in past 2 years except certain skin or cervical cancers.
- Personal or family history of malignant hyperthermia.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 hours
Participants receive TLC590, Liposomal Bupivacaine, or Saline Placebo following bunionectomy to manage postsurgical pain.
1 treatment visit during surgery and monitoring through 72 hours postsurgery
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
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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