Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain

Last updated: September 12, 2024
Sponsor: Taiwan Liposome Company
Overall Status: Completed

Phase

3

Condition

Osteoarthritis

Treatment

DSP

TLC599

Normal Saline

Clinical Study ID

NCT04123561
TLC599A3005
  • Ages > 40
  • All Genders

Study Summary

Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male or female ≥40 years of age. BMI ≤ 40 kg/m2. Radiographically documented OA with Kellgren-Lawrence severity Grade 2 or 3 and associated symptoms Patient-reported pain with NRS score ≥4 (on a 0-10 scale) Able to read, understand, and sign the informed consent form, communicate with the investigator, complete study diaries, and understand and comply with protocol requirements.

Exclusion

Exclusion Criteria:

Recent use of IA or systemic corticosteroids Patient who is not ambulatory Any surgery or arthroscopy in the index knee within 12 months Any condition that could possibly confound the patient's assessment of index knee pain Substance abuse disorder, or positive urine drug test for illegal drug substances History of acquired or congenital immunodeficiency diseases History of treated malignancy which is disease free for ≤5 years Known allergy or hypersensitivity to the study drugs or their components

Study Design

Total Participants: 504
Treatment Group(s): 3
Primary Treatment: DSP
Phase: 3
Study Start date:
November 26, 2019
Estimated Completion Date:
February 03, 2022

Study Description

This is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled pivotal study. Approximately 500 adult patients with moderate to severe pain due to OA of the knee will be enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52.

Connect with a study center

  • Genesis Research Services

    Broadmeadow, New South Wales 2292
    Australia

    Site Not Available

  • Australian Clinical Research Network

    Maroubra, New South Wales 2035
    Australia

    Site Not Available

  • Northern Sydney Local Health District

    Saint Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Austrials

    Taringa, Queensland 4068
    Australia

    Site Not Available

  • Colin Bayliss Research and Teaching Unit

    Victoria Park, Western Australia 6100
    Australia

    Site Not Available

  • Affinity Orthopedic Specialists Llc

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • Cahaba Research, Inc

    Birmingham, Alabama 35242
    United States

    Site Not Available

  • Shoals Medical Trials Inc

    Sheffield, Alabama 35660
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Gb Family Care

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • Clinical Research Institute of Arizona Llc

    Surprise, Arizona 85374
    United States

    Site Not Available

  • Noble Clinical Research Llc

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Biosolutions Clinical Research Center

    La Mesa, California 919142
    United States

    Site Not Available

  • Translational Reseach Group Inc Dba Providence Clinical Research

    North Hollywood, California 91606
    United States

    Site Not Available

  • Prospective Research Innovations Inc

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Site Not Available

  • Chase Medical Research Llc

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Tampa Bay Medical Research

    Clearwater, Florida 32789
    United States

    Site Not Available

  • University Clinical Research-Deland, Llc Dba Accel Clinical Research

    DeLand, Florida 32720
    United States

    Site Not Available

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida 33216
    United States

    Site Not Available

  • Charter Research, Llc

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Well Pharma Medical Research Corp

    Miami, Florida 33143
    United States

    Site Not Available

  • Conquest Research, Llc

    Orlando, Florida 32822
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33603
    United States

    Site Not Available

  • Conquest Research (Winter Park)

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Drug Studies America

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Georgia Institute For Clinical Research Llc

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Better Health Clinical Research Inc

    Newnan, Georgia 30265
    United States

    Site Not Available

  • Chicago Clinical Research Institute, Inc.

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Healthcare Research Network Ii, Llc

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Affinity Health

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Medisphere Medical Research Center Llc

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Professional Research Network of Kansas Llc

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Delricht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Drug Trials America

    Hartsdale, New York 10530
    United States

    Site Not Available

  • Lillestol Research Llc

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Lowcountry Orthopedics C/O Coastal Carolina research center

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Clinical Investigations of Texas

    Plano, Texas 75075
    United States

    Site Not Available

  • Clinical Trials of Texas Inc (Ctt)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Quality Research Inc

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Charlottesville Medical Research Center Llc

    Charlottesville, Virginia 22911
    United States

    Site Not Available

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