Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Sponsor
Taiwan Liposome Company
Study ID
NCT05161637
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Postsurgical Pain Management

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TLC590 — DRUG
    TLC590 490mg or 588mg
  • Bupivacain — DRUG
    Bupivacaine 75mg
  • Ropivacaine — DRUG
    Ropivacaine 150mg
  • Normal saline — DRUG
    Normal saline 20mL or 24mL

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
415 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TLC590 490mg
    TLC590 490mg (20mL)
  • Experimental: TLC590 588mg
    TLC590 588mg (24mL)
  • Active Comparator: Bupivacaine 75mg
    Bupivacaine HCl 75mg (30mL)
  • Active Comparator: Ropivacaine
    Ropivacaine HCl 150mg (30mL) (Part 1)
  • Placebo Comparator: Normal saline
    Normal Saline 0.9% (20mL or 24mL)

Primary Outcome Measure

Part 1 - AUC 0-24 of NPRS-M [ Time Frame: 0-24 hours ]

Central Contacts

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