Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05161637
Study type Interventional
Source Taiwan Liposome Company
Contact Grace Tsao
Phone +886-2-26557377
Email grace@tlcbio.com
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date April 2025
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT05769855 - A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy Phase 3
Completed NCT05376904 - A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy. Phase 2
Active, not recruiting NCT04699175 - A Trial of HR021618 in Postsurgical Pain Management Phase 2