Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain (EXCELLENCE)
Osteoarthritis of the Knee
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility Criteria
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
Sites / Locations
- Cahaba Research, Inc
- Affinity Orthopedic Specialists Llc
- Shoals Medical Trials Inc
- Gb Family Care
- Arizona Research Center
- Clinical Research Institute of Arizona Llc
- Noble Clinical Research Llc
- Biosolutions Clinical Research Center
- Translational Reseach Group Inc Dba Providence Clinical Research
- Prospective Research Innovations Inc
- Encompass Clinical Research
- Chase Medical Research Llc
- Tampa Bay Medical Research
- University Clinical Research-Deland, Llc Dba Accel Clinical Research
- Jacksonville Center For Clinical Research
- Charter Research, Llc
- Well Pharma Medical Research Corp
- Conquest Research, Llc
- Progressive Medical Research
- Clinical Research of West Florida
- Conquest Research (Winter Park)
- Drug Studies America
- Georgia Institute For Clinical Research Llc
- Better Health Clinical Research Inc
- Chicago Clinical Research Institute, Inc.
- Northwestern University
- Healthcare Research Network Ii, Llc
- Affinity Health
- Medisphere Medical Research Center Llc
- Professional Research Network of Kansas Llc
- Delricht Research
- Healthcare Research Network
- Albuquerque Clinical Trials, Inc.
- Drug Trials America
- Lillestol Research Llc
- Altoona Center For Clinical Research
- Lowcountry Orthopedics C/O Coastal Carolina research center
- Clinical Investigations of Texas
- Quality Research Inc
- Clinical Trials of Texas Inc (Ctt)
- Charlottesville Medical Research Center Llc
- Genesis Research Services
- Australian Clinical Research Network
- Northern Sydney Local Health District
- Austrials
- Colin Bayliss Research and Teaching Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
TLC599
Dexamethasone sodium phosphate
Normal Saline
TLC599 (1mL) IA injection
DSP 4mg (1mL) IA injection
Normal saline (1mL) IA injection