NCT03838133

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hallux Valgus

Interventions

Type	Name	Description
DRUG	TLC590	TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients
DRUG	Naropin®	Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)
DRUG	Normal Saline	Normal Saline (0.9% sodium chloride, 10ml)
DRUG	Bupivacaine	Bupivacaine 50 mg (0.5%, 10 mL)

Timeline

• Start date: 2019-03-05
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-02-12
• Last updated: 2020-04-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study