Postsurgical Pain ManagementPhase 2/3NCT05161637
Phase 2/3 Study of TLC590 for Postsurgical Pain Management
A Phase 2/3 study testing TLC590, Bupivacain and Ropivacaine in people with Postsurgical Pain Management, run by Taiwan Liposome Company.
Trial summary
A phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postsurgical Pain Management
- What is being tested?
- TLC590, Bupivacain and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years old
- BMI 18-39 kg/m2
- Scheduled to undergo a primary, unilateral Lichtenstein inguinal hernia repair with mesh
- ASA Physical Status Classification of 1, 2 or 3
Who cannot join
- Clinically significant abnormal clinical laboratory test value
- Clinically significant 12-lead ECG
- History of orthostatic hypotension or syncope
- History of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition
- History of seizure or currently taking anticonvulsants
- History of hypersensitivity to bupivacaine/ropivacaine, any other amide-type local anesthetic, propofol, oxycodone or morphine (or other opioids)
Show all 18Show fewer
- History of severe or refractory post-operative nausea or vomiting (PONV)
- Abnormalities of laboratory parameters: HbA1c, platelet, hemoglobin, WBC, serun bilirubin/alanine aminotransferase/aspartate aminotrasferase, serum creatinine, PTT/INR
- Concurrent acute, or chronic painful restrictive/physical condition
- Received opioid therapy for longer than 4 days per week
- Prohibited medication: aspirin and other anti-platelet medication, anticoagulants, class III antiarrhythmic drugs, strong CYP1A2 inhibitors,systemic corticosteroids, NSAID, opioid, bupivacaine or ropivacaine, any investigational product
- History of drug abuse or alcohol abuse
- Positive results on the urine drug screen or alcohol breath test
- History of HIV; active HBV or HCV
- An inguinal hernia repair in the last 3 months or has undergone 3 or more surgeries within 12 months
- Malignancy in the last 2 years
- Documented sleep apnea or on home continuous positive airway pressure treatment (CPAP)
- Personal or family history of malignant hyperthermia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 2/3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TLC590 for Postsurgical Pain Management Following Inguinal Hernia Repair
A phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery.
Read the detailed description
This is a phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery. This study includes 2 parts. An unblinded interim analysis will be performed after completion of part 1 (phase 2, approximately 115 subjects to be randomized for 2 different doses of TLC590, bupivacaine, ropivacaine, or placebo), for selecting a TLC590 dose for part 2 (phase 3, approximately 300 subjects to be randomized for TLC590, bupivacaine, or placebo).In this study, 2 doses of TLC590 24.5 mg/mL in inguinal hernia repair will be assessed in an initial phase 2 part before proceeding to a phase 3 pivotal evaluation.
- Conditions
- Postsurgical Pain Management
- Being tested
- TLC590, Bupivacain, Ropivacaine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC590Drug
Also called intestigational drug
TLC590 490mg or 588mg
BupivacainDrug
Also called active comparator
Bupivacaine 75mg
RopivacaineDrug
Also called active comparator
Ropivacaine 150mg
Normal salineDrug
Also called placebo
Normal saline 20mL or 24mL
| Study group | Role | What they receive |
|---|---|---|
| TLC590 490mg | Experimental | TLC590 490mg (20mL) Receives: Drug: TLC590 |
| TLC590 588mg | Experimental | TLC590 588mg (24mL) Receives: Drug: TLC590 |
| Bupivacaine 75mg | Active comparator | Bupivacaine HCl 75mg (30mL) Receives: Drug: Bupivacain |
| Ropivacaine | Active comparator | Ropivacaine HCl 150mg (30mL) (Part 1) Receives: Drug: Ropivacaine |
| Normal saline | Placebo comparator | Normal Saline 0.9% (20mL or 24mL) Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 - AUC 0-24 of NPRS-M
AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
Measured: 0-24 hours
Part 2 - AUC 0-72 of NPRS-M
AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
Measured: 0-72 hours
Secondary outcomes (3)
AUC 0-72 of NPRS-M (active comparator)
AUC 0-72 of NPRS-M (TLC590 vs Bupivacaine)
Measured: 0-72 hours
Proportion of opioid-free subjects through 72 hours (placebo)
Proportion of opioid-free subjects through 72 hours (TLC590 vs. Placebo)
Measured: 0-72 hours
Proportion of opioid-free subjects through 72 hours (active comparator)
Proportion of opioid-free subjects through 72 hours (TLC590 vs. Bupivacaine)
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry Tai, PhD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161637
- Sponsor's protocol ID
- TLC590A2003
- Status last verified
- Apr 2024
- First submitted
- 3 Dec 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TLC590 for Postsurgical Pain Management Following Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05161637
- Acronym / sponsor ID
- TLC590A2003
- Conditions
- Postsurgical Pain Management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery.
Detailed description
This is a phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery. This study includes 2 parts. An unblinded interim analysis will be performed after completion of part 1 (phase 2, approximately 115 subjects to be randomized for 2 different doses of TLC590, bupivacaine, ropivacaine, or placebo), for selecting a TLC590 dose for part 2 (phase 3, approximately 300 subjects to be randomized for TLC590, bupivacaine, or placebo).In this study, 2 doses of TLC590 24.5 mg/mL in inguinal hernia repair will be assessed in an initial phase 2 part before proceeding to a phase 3 pivotal evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TLC590 490mg | Experimental | Drug: TLC590TLC590 490mg (20mL) |
| TLC590 588mg | Experimental | Drug: TLC590TLC590 588mg (24mL) |
| Bupivacaine 75mg | Active comparator | Drug: BupivacainBupivacaine HCl 75mg (30mL) |
| Ropivacaine | Active comparator | Drug: RopivacaineRopivacaine HCl 150mg (30mL) (Part 1) |
| Normal saline | Placebo comparator | Drug: Normal salineNormal Saline 0.9% (20mL or 24mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 18 years old
- BMI 18-39 kg/m2
- Scheduled to undergo a primary, unilateral Lichtenstein inguinal hernia repair with mesh
- ASA Physical Status Classification of 1, 2 or 3
Key exclusion criteria (18 listed)
- Clinically significant abnormal clinical laboratory test value
- Clinically significant 12-lead ECG
- History of orthostatic hypotension or syncope
- History of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition
- History of seizure or currently taking anticonvulsants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC590Also: intestigational drugTLC590 490mg or 588mg | Drug | TLC590 490mg, TLC590 588mg |
| BupivacainAlso: active comparatorBupivacaine 75mg | Drug | Bupivacaine 75mg |
| RopivacaineAlso: active comparatorRopivacaine 150mg | Drug | Ropivacaine |
| Normal salineAlso: placeboNormal saline 20mL or 24mL | Drug | Normal saline |
Primary outcome
Part 1 - AUC 0-24 of NPRS-M
Time frame: 0-24 hours
AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
Part 2 - AUC 0-72 of NPRS-M
Time frame: 0-72 hours
AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
3 secondary outcomes
AUC 0-72 of NPRS-M (active comparator)
Time frame: 0-72 hours
Proportion of opioid-free subjects through 72 hours (placebo)
Time frame: 0-72 hours
Proportion of opioid-free subjects through 72 hours (active comparator)
Time frame: 0-72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Tai, PhD study director
Taiwan Liposome Company
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TLC590, Bupivacain and Ropivacaine in people with Postsurgical Pain Management, run by Taiwan Liposome Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace Tsao (+886-2-26557377, grace@tlcbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 - AUC 0-24 of NPRS-M (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.