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

NCT04123561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2024-10-08

Study results available
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Summary

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

Conditions

  • Osteoarthritis of the Knee

Interventions

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

Sponsors & Collaborators

  • Taiwan Liposome Company

    lead INDUSTRY

Principal Investigators

  • Carl Brown, PhD · Taiwan Liposome Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2022-02-03
Completion
2022-02-03
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123561 on ClinicalTrials.gov