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Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Sponsor
Taiwan Liposome Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05161637
Collaborator
(none)
415
Enrollment
5
Arms
22
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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

Study Type:
Interventional
Anticipated Enrollment :
415 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: TLC590 490mg

TLC590 490mg (20mL)

Drug: TLC590
TLC590 490mg or 588mg
Other Names:
  • intestigational drug

    		•
    Experimental: TLC590 588mg

    TLC590 588mg (24mL)

    Drug: TLC590
    TLC590 490mg or 588mg
    Other Names:
  • intestigational drug

    		•
    Active Comparator: Bupivacaine 75mg

    Bupivacaine HCl 75mg (30mL)

    Drug: Bupivacain
    Bupivacaine 75mg
    Other Names:
  • active comparator

    		•
    Active Comparator: Ropivacaine

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

    Drug: Ropivacaine
    Ropivacaine 150mg
    Other Names:
  • active comparator

    		•
    Placebo Comparator: Normal saline

    Normal Saline 0.9% (20mL or 24mL)

    Drug: Normal saline
    Normal saline 20mL or 24mL
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part 1 - AUC 0-24 of NPRS-M [0-24 hours]

      AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo

    2. Part 2 - AUC 0-72 of NPRS-M [0-72 hours]

      AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo

    Secondary Outcome Measures

    1. AUC 0-72 of NPRS-M (active comparator) [0-72 hours]

      AUC 0-72 of NPRS-M (TLC590 vs Bupivacaine)

    2. Proportion of opioid-free subjects through 72 hours (placebo) [0-72 hours]

      Proportion of opioid-free subjects through 72 hours (TLC590 vs. Placebo)

    3. Proportion of opioid-free subjects through 72 hours (active comparator) [0-72 hours]

      Proportion of opioid-free subjects through 72 hours (TLC590 vs. Bupivacaine)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Taiwan Liposome Company

    Investigators

    • Study Director: Carl Brown, PhD, Taiwan Liposome Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taiwan Liposome Company
    ClinicalTrials.gov Identifier:
    NCT05161637
    Other Study ID Numbers:
    • TLC590A2003
    First Posted:
    Dec 17, 2021
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine
    Ropivacaine

    Study Results

    No Results Posted as of Jul 8, 2022