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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Taiwan Liposome Company
Study ID
NCT03838133
Phase
PHASE2
Status
Completed

Conditions

  • Hallux Valgus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • TLC590 — DRUG
    TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients
  • Naropin® — DRUG
    Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)
  • Normal Saline — DRUG
    Normal Saline (0.9% sodium chloride, 10ml)
  • Bupivacaine — DRUG
    Bupivacaine 50 mg (0.5%, 10 mL)

Study Details

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.

Key Dates

Start date
Mar 5, 2019
Status verified
Apr 2020
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: TLC590 dose 1 (152 mg)
    TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
  • Experimental: TLC590 dose 2 (190 mg)
    TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
  • Experimental: TLC590 dose 3 (228 mg)
    TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
  • Active Comparator: Naropin®
    Naronpin injection contains ropivacaine HCl 50 mg (0.5%, 10 mL)
  • Placebo Comparator: Placebo
    Normal Saline (0.9% sodium chloride, 10 mL)
  • Active Comparator: Bupivacaine
    Bupivacaine HCl 50 mg (0.5%, 10 mL)

Primary Outcome Measure

AUC of numerical pain rating scale [ Time Frame: 0-24 hours, 0-72 hours ]

Locations (5)

FacilityCityStateZIPSite coordinators
Arizona Research CenterPhoenixArizona85053-
Anaheim Clinical Trials, LLCAnaheimCalifornia92801-
Chesapeake Research GroupPasadenaMaryland21122-1020-
Endeavor Clinical TrialsSan AntonioTexas78229-
JBR clinical researchDraperUtah84020-

Find similar trials in Phoenix, AZ

By research site
Arizona Research Center· Phoenix, AZAnaheim Clinical Trials, LLC· Anaheim, CAChesapeake Research Group· Pasadena, MDEndeavor Clinical Trials· San Antonio, TXJBR clinical research· Draper, UT

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