TLC590 for Postsurgical Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TLC590 for managing pain after bunion surgery. The researchers aim to determine if TLC590 provides better pain relief than bupivacaine, a commonly used painkiller, or a placebo (a substance with no active ingredient). Individuals scheduled for bunion surgery without serious medical issues might be suitable for this study. Participants will receive one of the treatments to compare their effectiveness and safety in reducing postsurgical pain. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potential new pain management option.
Will I have to stop taking my current medications?
The trial does not clearly state if you must stop all current medications, but it does exclude those using certain medications before the surgery. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that TLC590 is likely to be safe for humans?
Research has shown that TLC590, a non-opioid pain relief treatment, holds promise for managing post-surgical pain. Earlier studies tested TLC590 on patients undergoing various surgeries, and the results indicated it reduced pain more effectively than both a placebo and bupivacaine over a week.
Regarding safety, previous research suggests that TLC590 is generally well-tolerated. No major safety issues were reported, and patients did not experience significant side effects in those trials. Ongoing studies aim to confirm these findings, but current evidence reassures those considering participation in new trials.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for postsurgical pain, which often involves opioids or traditional local anesthetics like bupivacaine, TLC590 is unique due to its extended-release formulation. This treatment utilizes lipid-based technology to slowly release the active anesthetic over time, potentially providing longer-lasting pain relief with fewer doses. Researchers are excited about TLC590 because it could reduce the need for opioids, minimizing side effects and the risk of addiction while maintaining effective pain management.
What evidence suggests that TLC590 might be an effective treatment for postsurgical pain?
Research has shown that TLC590, which participants in this trial may receive, effectively manages post-surgical pain. In earlier studies, TLC590 provided more pain relief than both a placebo and bupivacaine, another pain medication tested in this trial. TLC590 significantly reduced pain within the first 24 hours after surgery, with relief lasting up to 168 hours. This suggests that TLC590 may offer longer-lasting pain relief than some current treatments. As a non-opioid, it is not addictive. These findings indicate that TLC590 could be a strong option for managing pain after surgeries like bunion removal.13467
Who Is on the Research Team?
Tien-Tzu Tai, MD
Principal Investigator
Taiwan Liposome Company
Are You a Good Fit for This Trial?
This trial is for adults who have undergone bunion surgery and are experiencing postoperative pain. Specific eligibility details aren't provided, but typically participants must be in good health aside from the condition being studied.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TLC590 or comparator via local infiltration following bunionectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TLC590
Find a Clinic Near You
Who Is Running the Clinical Trial?
TLC Biopharmaceuticals, Inc.
Lead Sponsor