At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
FX006 32 mg +1 moredrug
Likely dose
FX006 32 mgfrom 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 Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)
In Brief
A Phase 2 clinical trial evaluating FX006 32 mg and TAcs 40 mg for Bilateral Knee Osteoarthritis. Completed, enrolled 24 participants across 3 sites.
Detailed Summary
This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBilateral Knee Osteoarthritis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartDec 2017
First PostedDec 2017
Primary CompletionMar 2018
TodayJul 2026
First PostedDec 19, 2017
Enrollment StartDec 6, 2017
Primary CompletionMar 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.5 years ago
Interventions
FX006 32 mgdrug
Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
TAcs 40 mgdrug
Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)