drugset / Trial / NCT04123561
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Timeline
- Start
- 2019-11-26
- Primary completion
- 2022-02-03
- Completion
- 2022-02-03
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN TLC599 12mg: -0.968 (-1.060 to -0.877) score on a scale NCT04123561 ↗
registry analysis (superiority test); TLC599 12mg vs Placebo; p = 0.0372; Least Squares Mean Difference (LSMD) -0.171 (95% CI -0.331 to -0.010); ANCOVA NCT04123561 ↗
release “At Week 12, TLC599 was statistically superior to placebo in WOMAC Pain (p<0.05, the primary endpoint).” tlcbio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 4 mg | Other |
| Subject | TLC599 | Other / unclassified | 1 ml | Other |