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

NCT03838133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-04-07

No results posted yet for this study

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.

Conditions

  • Hallux Valgus

Interventions

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)

Sponsors & Collaborators

  • Taiwan Liposome Company

    lead INDUSTRY

Principal Investigators

  • Carl Brown, PhD · Taiwan Liposome Company

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03838133 on ClinicalTrials.gov