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

NCT ID: NCT04123561

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-26

Study Completion Date

2022-02-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TLC599

TLC599 (1mL) IA injection

Group Type EXPERIMENTAL

TLC599

Intervention Type DRUG

TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)

Dexamethasone sodium phosphate

DSP 4mg (1mL) IA injection

Group Type ACTIVE_COMPARATOR

TLC599

Intervention Type DRUG

TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)

DSP

Intervention Type DRUG

Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.

Normal Saline

Normal saline (1mL) IA injection

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

0.9% normal saline

Interventions

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TLC599

TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)

Intervention Type DRUG

DSP

Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.

Intervention Type DRUG

Normal Saline

0.9% normal saline

Intervention Type OTHER

Other Intervention Names

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TLC599 Injection Dexamethasone Sodium Phosphate

Eligibility Criteria

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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 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taiwan Liposome Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Brown, PhD

Role: STUDY_DIRECTOR

Taiwan Liposome Company

Locations

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Cahaba Research, Inc

Birmingham, Alabama, United States

Site Status

Affinity Orthopedic Specialists Llc

Birmingham, Alabama, United States

Site Status

Shoals Medical Trials Inc

Sheffield, Alabama, United States

Site Status

Gb Family Care

Phoenix, Arizona, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Clinical Research Institute of Arizona Llc

Surprise, Arizona, United States

Site Status

Noble Clinical Research Llc

Tucson, Arizona, United States

Site Status

Biosolutions Clinical Research Center

La Mesa, California, United States

Site Status

Translational Reseach Group Inc Dba Providence Clinical Research

North Hollywood, California, United States

Site Status

Prospective Research Innovations Inc

Rancho Cucamonga, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

Chase Medical Research Llc

Waterbury, Connecticut, United States

Site Status

Tampa Bay Medical Research

Clearwater, Florida, United States

Site Status

University Clinical Research-Deland, Llc Dba Accel Clinical Research

DeLand, Florida, United States

Site Status

Jacksonville Center For Clinical Research

Jacksonville, Florida, United States

Site Status

Charter Research, Llc

Lady Lake, Florida, United States

Site Status

Well Pharma Medical Research Corp

Miami, Florida, United States

Site Status

Conquest Research, Llc

Orlando, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Clinical Research of West Florida

Tampa, Florida, United States

Site Status

Conquest Research (Winter Park)

Winter Park, Florida, United States

Site Status

Drug Studies America

Marietta, Georgia, United States

Site Status

Georgia Institute For Clinical Research Llc

Marietta, Georgia, United States

Site Status

Better Health Clinical Research Inc

Newnan, Georgia, United States

Site Status

Chicago Clinical Research Institute, Inc.

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Healthcare Research Network Ii, Llc

Flossmoor, Illinois, United States

Site Status

Affinity Health

Oak Brook, Illinois, United States

Site Status

Medisphere Medical Research Center Llc

Evansville, Indiana, United States

Site Status

Professional Research Network of Kansas Llc

Wichita, Kansas, United States

Site Status

Delricht Research

New Orleans, Louisiana, United States

Site Status

Healthcare Research Network

Hazelwood, Missouri, United States

Site Status

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, United States

Site Status

Drug Trials America

Hartsdale, New York, United States

Site Status

Lillestol Research Llc

Fargo, North Dakota, United States

Site Status

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Lowcountry Orthopedics C/O Coastal Carolina research center

North Charleston, South Carolina, United States

Site Status

Clinical Investigations of Texas

Plano, Texas, United States

Site Status

Quality Research Inc

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas Inc (Ctt)

San Antonio, Texas, United States

Site Status

Charlottesville Medical Research Center Llc

Charlottesville, Virginia, United States

Site Status

Genesis Research Services

Broadmeadow, New South Wales, Australia

Site Status

Australian Clinical Research Network

Maroubra, New South Wales, Australia

Site Status

Northern Sydney Local Health District

Saint Leonards, New South Wales, Australia

Site Status

Austrials

Taringa, Queensland, Australia

Site Status

Colin Bayliss Research and Teaching Unit

Victoria Park, Western Australia, Australia

Site Status

Countries

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United States Australia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TLC599A3005

Identifier Type: -

Identifier Source: org_study_id

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