Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Source: ClinicalTrials.gov NCT04123561 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo |
-0.968; -0.798 | 0.0372 sig |
| SECONDARY Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo |
-0.929; -0.798 | — |
| SECONDARY Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo |
-0.873; -0.749 | — |
| SECONDARY Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo |
-0.845; -0.688 | — |
| SECONDARY Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo |
-0.964; -0.882 | — |
| SECONDARY Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo |
-0.903; -0.735 | — |
| SECONDARY PGIC at Week 12 for TLC599 12mg Versus Placebo |
2.554; 2.791 | — |
| SECONDARY Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo |
15.568; 29.803 | — |
| SECONDARY Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo |
45.5; 39.0 | — |
| SECONDARY Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo |
-0.907; -0.787 | — |
| SECONDARY PGIC at Week 36 for TLC599 12mg Versus Placebo |
2.635; 2.738 | — |
| SECONDARY Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg |
-0.968; -0.933 | — |
| SECONDARY Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo |
-0.928; -0.934 | — |
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
Data sourced from ClinicalTrials.gov (NCT04123561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.