At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 504 enrolled
Drug / intervention
TLC599 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating TLC599, DSP, and 1 other intervention for Osteoarthritis of the Knee. Completed, enrolled 504 participants across 46 sites in 2 countries.
Detailed Summary
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartNov 2019
Primary CompletionFeb 2022
TodayJul 2026
First PostedOct 11, 2019
Enrollment StartNov 26, 2019
Primary CompletionFeb 3, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.7 years ago
Interventions
TLC599drug
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
DSPdrug
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.
Normal Salineother
0.9% normal saline