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

2019-10-17 11:03:48 | BioPortfolio

Summary

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

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 with Placebo and DSP through Week 52.

Study Design

Conditions

Osteoarthritis of the Knee

Intervention

TLC599, DSP, Normal Saline

Status

Not yet recruiting

Source

Taiwan Liposome Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-17T11:03:48-0400

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Medical and Biotech [MESH] Definitions

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A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

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