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Phase 2/3 Study of TLC590 for Postsurgical Pain Management
Sponsor: Taiwan Liposome Company
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
415
Start Date
2025-04
Completion Date
2025-12
Last Updated
2024-04-11
Healthy Volunteers
No
Conditions
Interventions
TLC590
TLC590 490mg or 588mg
Bupivacain
Bupivacaine 75mg
Ropivacaine
Ropivacaine 150mg
Normal saline
Normal saline 20mL or 24mL