A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

Hallux Valgus Clinical Trial

Official title: A Phase 2, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

Status Completed

Clinical Trial Summary

This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.

Clinical Trial Description

This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.

The primary objective of this study is to evaluate the analgesic efficacy of TLC590 for post-surgical pain management in subjects following bunionectomy.

The secondary objectives of this study are:

• To evaluate the pharmacokinetic (PK) profile and dose-exposure relationship of TLC590, as well as the bioavailability as compared with Naropin®.

• To evaluate the safety and tolerability of TLC590 for post-surgical pain management in subjects following bunionectomy.

• To evaluate the exposure-response relationship between PK parameters and pain intensity.

The study will be divided into two parts:

Part 1: Blinded Pharmacokinetics of TLC590 and Naropin®. Approximately 48 subjects will be randomized to treatments.

Part 2: Efficacy and Safety of TLC590 versus bupivacaine and Placebo. Part 2 of the study will randomize approximately 150 evaluable subjects who meet all entry criteria. ;

Related Conditions & MeSH terms

• Hallux Valgus

• NCT number: NCT03838133
• Study type: Interventional
• Source: Taiwan Liposome Company
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2019
• Completion date: March 31, 2020