- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123561
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain (EXCELLENCE)
A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Broadmeadow, New South Wales, Australia, 2292
- Genesis Research Services
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Maroubra, New South Wales, Australia, 2035
- Australian Clinical Research Network
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Saint Leonards, New South Wales, Australia, 2065
- Northern Sydney Local Health District
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Queensland
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Taringa, Queensland, Australia, 4068
- AusTrials
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Western Australia
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Victoria Park, Western Australia, Australia, 6100
- Colin Bayliss Research and Teaching Unit
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Alabama
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Birmingham, Alabama, United States, 35242
- Cahaba Research, Inc
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Birmingham, Alabama, United States, 35243
- Affinity Orthopedic Specialists Llc
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Sheffield, Alabama, United States, 35660
- Shoals Medical Trials Inc
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Arizona
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Phoenix, Arizona, United States, 85053
- Arizona Research Center
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Phoenix, Arizona, United States, 85037
- GB Family Care
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Surprise, Arizona, United States, 85374
- Clinical Research Institute of Arizona Llc
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Tucson, Arizona, United States, 85704
- Noble Clinical Research Llc
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California
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La Mesa, California, United States, 919142
- Biosolutions Clinical Research Center
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North Hollywood, California, United States, 91606
- Translational Reseach Group Inc Dba Providence Clinical Research
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Rancho Cucamonga, California, United States, 91730
- Prospective Research Innovations Inc
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Spring Valley, California, United States, 91978
- Encompass Clinical Research
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Chase Medical Research LLC
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Florida
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Clearwater, Florida, United States, 32789
- Tampa Bay Medical Research
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DeLand, Florida, United States, 32720
- University Clinical Research-Deland, Llc Dba Accel Clinical Research
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Jacksonville, Florida, United States, 33216
- Jacksonville Center for Clinical Research
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Lady Lake, Florida, United States, 32159
- Charter Research, LLC
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Miami, Florida, United States, 33143
- Well Pharma Medical Research Corp
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Orlando, Florida, United States, 32822
- Conquest Research, LLC
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Port Orange, Florida, United States, 32127
- Progressive Medical Research
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Tampa, Florida, United States, 33603
- Clinical Research of West Florida
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Winter Park, Florida, United States, 32789
- Conquest Research (Winter Park)
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Georgia
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Marietta, Georgia, United States, 30060
- Drug Studies America
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Marietta, Georgia, United States, 30060
- Georgia Institute For Clinical Research LLC
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Newnan, Georgia, United States, 30265
- Better Health Clinical Research Inc
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60607
- Chicago Clinical Research Institute, Inc.
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Flossmoor, Illinois, United States, 60422
- Healthcare Research Network II, LLC
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Oak Brook, Illinois, United States, 60523
- Affinity Health
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Indiana
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Evansville, Indiana, United States, 47714
- Medisphere Medical Research Center LLC
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Kansas
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Wichita, Kansas, United States, 67205
- Professional Research Network of Kansas Llc
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Louisiana
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New Orleans, Louisiana, United States, 70115
- Delricht Research
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Missouri
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Hazelwood, Missouri, United States, 63042
- Healthcare Research Network
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Albuquerque Clinical Trials, Inc.
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New York
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Hartsdale, New York, United States, 10530
- Drug Trials America
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North Dakota
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Fargo, North Dakota, United States, 58104
- Lillestol Research LLC
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
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South Carolina
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North Charleston, South Carolina, United States, 29406
- Lowcountry Orthopedics C/O Coastal Carolina research center
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Texas
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Plano, Texas, United States, 75075
- Clinical Investigations of Texas
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San Antonio, Texas, United States, 78209
- Quality Research Inc
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas Inc (Ctt)
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Virginia
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Charlottesville, Virginia, United States, 22911
- Charlottesville Medical Research Center LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TLC599
TLC599 (1mL) IA injection
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TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
Other Names:
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Active Comparator: Dexamethasone sodium phosphate
DSP 4mg (1mL) IA injection
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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.
Other Names:
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
Other Names:
|
Placebo Comparator: Normal Saline
Normal saline (1mL) IA injection
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0.9% normal saline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in WOMAC Pain
Time Frame: Baseline, Week 12
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Change from Baseline in WOMAC Pain
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in WOMAC Pain
Time Frame: Baseline, Week 16
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Change from Baseline in WOMAC Pain
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Baseline, Week 16
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Change from Baseline in WOMAC Pain
Time Frame: Baseline, Week 20
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Change from Baseline in WOMAC Pain
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Baseline, Week 20
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Change from Baseline in WOMAC Pain
Time Frame: Baseline, Week 24
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Change from Baseline in WOMAC Pain
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Baseline, Week 24
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Change from Baseline in WOMAC Pain
Time Frame: Baseline, Week 36
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Change from Baseline in WOMAC Pain
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Baseline, Week 36
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Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)
Time Frame: Baseline, Week 12
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Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)
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Baseline, Week 12
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PGIC
Time Frame: Week 12
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Patient Global Impression of Change
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Week 12
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Total rescue acetaminophen consumption
Time Frame: through Week 12
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Total rescue acetaminophen consumption
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through Week 12
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Durable responder with ≥30% decrease in WOMAC Pain from Baseline
Time Frame: Weeks 4 through 12
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Durable responder with ≥30% decrease in WOMAC Pain from Baseline
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Weeks 4 through 12
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Change from Baseline in WOMAC Function
Time Frame: Baseline, Week 36
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Change from Baseline in WOMAC Function
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Baseline, Week 36
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PGIC
Time Frame: Week 36
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Patient Global Impression of Change
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Week 36
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Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)
Time Frame: Baseline, Week 12
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Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)
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Baseline, Week 12
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Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)
Time Frame: Baseline, Week 52
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Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)
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Baseline, Week 52
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Dexamethasone 21-phosphate
Other Study ID Numbers
- TLC599A3005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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