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Local Anesthetic
TLC590 for Postoperative Pain
Phase 2
Recruiting
Research Sponsored by Taiwan Liposome Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo one of the following elective surgeries: Unilateral first metatarsal bunionectomy, Laparoscopy-assisted open ventral hernia repair, Breast augmentation, Unilateral total knee arthroplasty, Abdominoplasty (tummy tuck)
Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled
Must not have
History of cardiac arrhythmia or taking specific antiarrhythmic drugs
History of severe or refractory postoperative nausea and vomiting (PONV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how a medication called TLC590 works in the body and its safety when used in different surgical procedures. The researchers want to find the highest dose of TLC590 that can be tolerated
Who is the study for?
This trial is for individuals undergoing certain surgeries (like bunionectomy, hernia repair, breast augmentation, tummy tuck, or knee replacement) who need pain management post-operation. Specific eligibility criteria are not provided here.
What is being tested?
The study is testing TLC590 to see how it's processed in the body and its safety across different surgeries. It compares TLC590 with a standard pain relief injection called ropivacaine to find the highest dose patients can tolerate without severe side effects.
What are the potential side effects?
While specific side effects of TLC590 aren't listed here, similar drugs often cause issues like nausea, numbness around the injection site, low blood pressure, dizziness or headaches. The trial will monitor these closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery, such as bunion removal, hernia repair, breast augmentation, knee replacement, or a tummy tuck.
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I am between 18 and 70 years old. If it's for breast augmentation, I am female.
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I am healthy or have mild systemic disease.
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I am a male and sterile, use birth control, or practice abstinence.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of irregular heartbeats or take medication for it.
Select...
I have had severe nausea or vomiting after surgery that was hard to treat.
Select...
I am using oxygen therapy now.
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I have a history of fainting or sudden drops in blood pressure.
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I have a history of seizures or am taking seizure medications.
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I have sleep apnea or use a CPAP machine at home.
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I or my family have a history of malignant hyperthermia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Part 3, Cohort 8Experimental Treatment1 Intervention
Abdominoplasty: The MTD of TLC590
Group II: Part 3, Cohort 7Experimental Treatment1 Intervention
Total Knee Arthroplasty: The MTD of TLC590
Group III: Part 3, Cohort 6Experimental Treatment1 Intervention
Laparoscopy-assisted Open Ventral Hernia: The MTD of TLC590
Group IV: Part 2, Cohort 5Experimental Treatment1 Intervention
Breast Augmentation: TLC590 with the SMC-suggested dose
Group V: Part 2, Cohort 4Experimental Treatment2 Interventions
Breast Augmentation: TLC590 or Ropivacaine
Group VI: Part 2, Cohort 3Experimental Treatment2 Interventions
Breast Augmentation: TLC590 or Ropivacaine
Group VII: Part 1, Cohort 2Experimental Treatment1 Intervention
Laparoscopy-assisted Open Ventral Hernia: TLC590
Group VIII: Part 1, Cohort 1Experimental Treatment1 Intervention
Bunionectomy: Increasing dose cohorts for TLC590
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TLC590
2018
Completed Phase 2
~220
Ropivacaine
2017
Completed Phase 4
~1960
Find a Location
Who is running the clinical trial?
Taiwan Liposome CompanyLead Sponsor
18 Previous Clinical Trials
1,716 Total Patients Enrolled
Tien-Tzu Tai, MDStudy DirectorTaiwan Liposome Company