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Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Primary Purpose

Postsurgical Pain Management

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TLC590
Bupivacain
Ropivacaine
Normal saline
Sponsored by
Taiwan Liposome Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postsurgical Pain Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    TLC590 490mg

    TLC590 588mg

    Bupivacaine 75mg

    Ropivacaine

    Normal saline

    Arm Description

    TLC590 490mg (20mL)

    TLC590 588mg (24mL)

    Bupivacaine HCl 75mg (30mL)

    Ropivacaine HCl 150mg (30mL) (Part 1)

    Normal Saline 0.9% (20mL or 24mL)

    Outcomes

    Primary Outcome Measures

    Part 1 - AUC 0-24 of NPRS-M
    AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
    Part 2 - AUC 0-72 of NPRS-M
    AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo

    Secondary Outcome Measures

    AUC 0-72 of NPRS-M (active comparator)
    AUC 0-72 of NPRS-M (TLC590 vs Bupivacaine)
    Proportion of opioid-free subjects through 72 hours (placebo)
    Proportion of opioid-free subjects through 72 hours (TLC590 vs. Placebo)
    Proportion of opioid-free subjects through 72 hours (active comparator)
    Proportion of opioid-free subjects through 72 hours (TLC590 vs. Bupivacaine)

    Full Information

    First Posted
    December 3, 2021
    Last Updated
    April 21, 2023
    Sponsor
    Taiwan Liposome Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05161637
    Brief Title
    Phase 2/3 Study of TLC590 for Postsurgical Pain Management
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taiwan Liposome Company

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postsurgical Pain Management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    415 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TLC590 490mg
    Arm Type
    Experimental
    Arm Description
    TLC590 490mg (20mL)
    Arm Title
    TLC590 588mg
    Arm Type
    Experimental
    Arm Description
    TLC590 588mg (24mL)
    Arm Title
    Bupivacaine 75mg
    Arm Type
    Active Comparator
    Arm Description
    Bupivacaine HCl 75mg (30mL)
    Arm Title
    Ropivacaine
    Arm Type
    Active Comparator
    Arm Description
    Ropivacaine HCl 150mg (30mL) (Part 1)
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Normal Saline 0.9% (20mL or 24mL)
    Intervention Type
    Drug
    Intervention Name(s)
    TLC590
    Other Intervention Name(s)
    intestigational drug
    Intervention Description
    TLC590 490mg or 588mg
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacain
    Other Intervention Name(s)
    active comparator
    Intervention Description
    Bupivacaine 75mg
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    active comparator
    Intervention Description
    Ropivacaine 150mg
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Other Intervention Name(s)
    placebo
    Intervention Description
    Normal saline 20mL or 24mL
    Primary Outcome Measure Information:
    Title
    Part 1 - AUC 0-24 of NPRS-M
    Description
    AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
    Time Frame
    0-24 hours
    Title
    Part 2 - AUC 0-72 of NPRS-M
    Description
    AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
    Time Frame
    0-72 hours
    Secondary Outcome Measure Information:
    Title
    AUC 0-72 of NPRS-M (active comparator)
    Description
    AUC 0-72 of NPRS-M (TLC590 vs Bupivacaine)
    Time Frame
    0-72 hours
    Title
    Proportion of opioid-free subjects through 72 hours (placebo)
    Description
    Proportion of opioid-free subjects through 72 hours (TLC590 vs. Placebo)
    Time Frame
    0-72 hours
    Title
    Proportion of opioid-free subjects through 72 hours (active comparator)
    Description
    Proportion of opioid-free subjects through 72 hours (TLC590 vs. Bupivacaine)
    Time Frame
    0-72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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) 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Grace Tsao
    Phone
    +886-2-26557377
    Email
    grace@tlcbio.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carl Brown, PhD
    Organizational Affiliation
    Taiwan Liposome Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Phase 2/3 Study of TLC590 for Postsurgical Pain Management

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