Status:
COMPLETED
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Lead Sponsor:
Taiwan Liposome Company
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Detailed 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 enrolle...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2022
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT04123561
Start Date
November 26 2019
End Date
February 3 2022
Last Update
October 8 2024
Active Locations (46)
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1
Cahaba Research, Inc
Birmingham, Alabama, United States, 35242
2
Affinity Orthopedic Specialists Llc
Birmingham, Alabama, United States, 35243
3
Shoals Medical Trials Inc
Sheffield, Alabama, United States, 35660
4
Gb Family Care
Phoenix, Arizona, United States, 85037