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Phase 2/3 Study of TLC590 for Postsurgical Pain Management

NCT05161637 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2024-04-11

No results posted yet for this study

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.

Conditions

  • Postsurgical Pain Management

Interventions

DRUG

TLC590

TLC590 490mg or 588mg

DRUG

Bupivacain

Bupivacaine 75mg

DRUG

Ropivacaine

Ropivacaine 150mg

DRUG

Normal saline

Normal saline 20mL or 24mL

Sponsors & Collaborators

  • Taiwan Liposome Company

    lead INDUSTRY

Principal Investigators

  • Terry Tai, PhD · Taiwan Liposome Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161637 on ClinicalTrials.gov