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New treatment option for Postsurgical Pain Management
Official title A Study on TLC590 for Managing Postsurgical Pain
ClinicalTrials.gov ID: NCT06574269
What this study is testing
What is TLC590?
TLC590 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for postsurgical pain management.
Also referred to as TLC590 (Ropivacaine Extended-Release Injectable Suspension).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures. Researchers aim to determine the maximum tolerated dose (MTD) of TLC590 via Safety Monitoring Committee (SMC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Able and willing to provide written informed consent
- Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled
- Scheduled to undergo one of the following elective surgeries, with no additional procedures and be able to use the anesthesia regimen:
- Unilateral first metatarsal bunionectomy (Cohort 1)
- Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6)
You likely can't join if
- A clinically significant abnormal clinical laboratory test value
- Evidence of a clinically significant 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...
- History of seizures or taking anticonvulsants during the Screening period
- History of cardiac arrhythmia or taking Class III antiarrhythmic drugs including amiodarone, dofetilide, dronedarone, sotalol, or ibutilide during...
See the full eligibility criteria
- Able and willing to provide written informed consent
- Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled
- Scheduled to undergo one of the following elective surgeries, with no additional procedures and be able to use the anesthesia regimen:
- Unilateral first metatarsal bunionectomy (Cohort 1)
- Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6)
- Breast augmentation (Cohort 3 through 5)
- Unilateral total knee arthroplasty (Cohort 7)
- Abdominoplasty (tummy tuck) (Cohort 8)
- ASA Physical Status Classification of 1 or 2
- Male people 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...
- Female people are eligible only if all the following apply:
- Not pregnant with a negative serum pregnancy test at Screening and negative urine pregnancy test on Day 1 before surgery (pregnancy test not required for females of non-childbearing potential, defined as surgically...
- Not lactating
- Not planning to become pregnant during the study
- If of childbearing potential, commits to the use of a highly effective method of birth control for the duration of the study and or at least 30 days after study drug administration
- BMI \>18 \~ ≤39 kg/m2
- A clinically significant abnormal clinical laboratory test value
- Evidence of a clinically significant 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 condition that has been assessed by the Investigator to be unsuitable...
- History of seizures or taking anticonvulsants during the Screening period
- History of cardiac arrhythmia or taking Class III antiarrhythmic drugs including amiodarone, dofetilide, dronedarone, sotalol, or ibutilide during the Screening period
- History of sleep apnea or on home CPAP treatment
- History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, hydromorphone, fentanyl, midazolam, acetaminophen, oxycodone, or morphine (or other opioids)
- 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, as assessed by the C-SSRS at Screening
- 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 (regularly drinks \>4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 2 years prior to...
- Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or non-prescribed drug or alcohol abuse at Screening or on Day 1 before surgery. Prescribed medication that is known to result...
- 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 the previous 6 months prior to Screening
- Is taking daily analgesics for longer than 4 days per week for a chronically painful condition during the Screening period. Not exclusionary if it is utilized for pain related to the total knee arthroplasty indication
- Is receiving oxygen therapy during the Screening period
- Use of any of the following medications within 5 half-lives prior to the study surgical procedure or as specified
- Malignancy in the last 2 years prior to Screening, 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
The study team makes the final eligibility decision.
Where it's taking place
- Bellaire, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bellaire, Texas, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.