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NOT YET RECRUITING
NCT05161637
PHASE2/PHASE3

Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Sponsor: Taiwan Liposome Company

View on ClinicalTrials.gov

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

Interventions

DRUG

TLC590

TLC590 490mg or 588mg

DRUG

Bupivacain

Bupivacaine 75mg

DRUG

Ropivacaine

Ropivacaine 150mg

DRUG

Normal saline

Normal saline 20mL or 24mL