At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 310 enrolled
Drug / intervention
FX006 32 mg +2 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 Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
In Brief
A Phase 2 clinical trial evaluating FX006 32 mg, Placebo, and 1 other intervention for Osteoarthritis of the Knee. Completed, enrolled 310 participants across 44 sites in 2 countries.
Detailed Summary
The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionNov 2015
TodayJul 2026
First PostedApr 17, 2014
Enrollment StartApr 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.2 years ago
Interventions
FX006 32 mgdrug
Single 5 mL IA injection
Placebodrug
Single 5 mL IA injection
FX006 16 mgdrug
Single 5 mL IA injection