drugset / Trial / NCT03838133

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

NCT03838133

Phase 2 Completed 150 enrolled Taiwan Liposome Company
RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2019-03-05
Primary completion
2020-03-31
Completion
2020-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 50 mg
Comparator Ropivacaine Other / unclassified 50 mg Other
Subject TLC590 Unknown 152 mg Other
Subject TLC590 Unknown 190 mg Other
Subject TLC590 Unknown 228 mg Other

Indications