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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)
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.
This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA. Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either: * extended-release FX006 64 mg total dose (approximately 12 patients) or * immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 \[calendar day of injection\], 2, 8, 15, 29, and 43.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
LA Biomed at Harbor-UCLA Medical Center
Torrance, California, United States
Rochester Clinical Research
Rochester, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Start Date
December 6, 2017
Primary Completion Date
March 14, 2018
Completion Date
March 14, 2018
Last Updated
January 24, 2024
24
ACTUAL participants
FX006 32 mg
DRUG
TAcs 40 mg
DRUG
Lead Sponsor
Pacira Pharmaceuticals, Inc
Data Source & Attribution
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