Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Completed · Phase 3
Conditions studied: Osteoarthritis of the Knee
In brief
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Key facts
- Study ID
- NCT04123561
- Run by
- Taiwan Liposome Company
- People needed
- 504
- Starts
- 2019-11-26
- Expected to finish
- 2022-02-03
- Last updated by the study team
- 2024-10-08
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cahaba Research, Inc — Birmingham, Alabama, United States
- Affinity Orthopedic Specialists Llc — Birmingham, Alabama, United States
- Shoals Medical Trials Inc — Sheffield, Alabama, United States
- Gb Family Care — Phoenix, Arizona, United States
- Arizona Research Center — Phoenix, Arizona, United States
- Clinical Research Institute of Arizona Llc — Surprise, Arizona, United States
- Noble Clinical Research Llc — Tucson, Arizona, United States
- Biosolutions Clinical Research Center — La Mesa, California, United States
- Translational Reseach Group Inc Dba Providence Clinical Research — North Hollywood, California, United States
- Prospective Research Innovations Inc — Rancho Cucamonga, California, United States
- Encompass Clinical Research — Spring Valley, California, United States
- Chase Medical Research Llc — Waterbury, Connecticut, United States
- Tampa Bay Medical Research — Clearwater, Florida, United States
- University Clinical Research-Deland, Llc Dba Accel Clinical Research — DeLand, Florida, United States
- Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
- Charter Research, Llc — Lady Lake, Florida, United States
- Well Pharma Medical Research Corp — Miami, Florida, United States
- Conquest Research, Llc — Orlando, Florida, United States
- Progressive Medical Research — Port Orange, Florida, United States
- Clinical Research of West Florida — Tampa, Florida, United States
- Conquest Research (Winter Park) — Winter Park, Florida, United States
- Drug Studies America — Marietta, Georgia, United States
- Georgia Institute For Clinical Research Llc — Marietta, Georgia, United States
- Better Health Clinical Research Inc — Newnan, Georgia, United States
- Chicago Clinical Research Institute, Inc. — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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