NCT04123561

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	TLC599	TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
DRUG	DSP	Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
OTHER	Normal Saline	0.9% normal saline

Timeline

• Start date: 2019-11-26
• Primary completion: 2022-02-03
• Completion: 2022-02-03
• First posted: 2019-10-11
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

46 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study