Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
CompletedPhase 3NCT04123561
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: TLC599
- Drug: DSP
- Other: Normal Saline
- Sponsor
- Taiwan Liposome Company
- Start date
- 2019-11-26
- Primary completion
- 2022-02-03
- Sex
- All
- Age range
- from 40 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia, United States
- Total sites listed
- 46
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04123561