NCT05161637

Phase 2/3 Study of TLC590 for Postsurgical Pain Management

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 415 (estimated)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postsurgical Pain Management

Interventions

Type	Name	Description
DRUG	TLC590	TLC590 490mg or 588mg
DRUG	Bupivacain	Bupivacaine 75mg
DRUG	Ropivacaine	Ropivacaine 150mg
DRUG	Normal saline	Normal saline 20mL or 24mL

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-12-17
• Last updated: 2024-04-11

Regulatory

• FDA-regulated drug study