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Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain — EXCELLENCE  

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Summary

Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.

Clinical Trial 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 enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04123561
Study type Interventional
Source Taiwan Liposome Company
Contact
Status Completed
Phase Phase 3
Start date November 26, 2019
Completion date February 3, 2022
View Details
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