Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management

Part of paid clinical trials in Draper, Utah.

Sponsor
Taiwan Liposome Company
Study ID
NCT03591146
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Inguinal Hernia

Eligibility Criteria

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

Interventions

  • TLC590 — DRUG
    TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
  • Naropin — DRUG
    Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL

Study Details

Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®

Key Dates

Start date
Jul 31, 2018
Status verified
Jun 2021
Primary completion
Jan 5, 2019
Completion
Jan 14, 2019

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: TLC590 190mg
    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 380mg
    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 570mg
    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 475mg
    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 150mg
    Naropin injection contains ropivacaine hydrochloride (HCl). Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial

Primary Outcome Measure

Safety and Tolerability: Event of SAE and Treatment-related Severe AE [ Time Frame: Screening till 30 days post investigational product (IP) administration, up to 58 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
JBR Clinical ResearchDraperUtah84020-

Find similar trials in Draper, UT

By research site
JBR Clinical Research· Draper, UT

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