At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 81 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.
An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee
In Brief
A Phase 2 clinical trial evaluating FX006 32 mg and TCA IR 40 for Osteoarthritis of the Knee. Completed, enrolled 81 participants across 4 sites.
Detailed Summary
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedDec 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedDec 22, 2015
Enrollment StartNov 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.5 years ago
Interventions
FX006 32 mgdrug
Single 5 mL IA injection
TCA IR 40drug
Single 1 mL IA injection