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The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.
This study will be a double-blind, randomized, parallel-group, active comparator design.
Twenty-four patients with knee osteoarthritis (OA) will be randomized to be treated with a single IA injection of 10, 40, or 60 mg of FX006 or 40 mg of commercially available triamcinolone acetonide.
Each patient will be evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics will be evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Osteoarthritis of the Knee
FX006, commercially available triamcinolone acetonide
Flexion Therapeutics, Inc.
Published on BioPortfolio: 2014-07-23T22:00:36-0400
This study is a double-blind, randomized, parallel group comparison of the effects of FX006 and Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in the protocol) o...
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This is an open-label, single administration study of 40 mg of FX006 conducted in male and female patients with Osteoarthritis (OA) of the knee.
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An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
Injuries to the knee or the knee joint.
A region of the lower extremity immediately surrounding and including the KNEE JOINT.
Arthritis is by definition the inflammation of one or more joints, characterized by swelling, pain, warmth, redness and diminished range of joint movement (Oxford Medical Dictionary). There are many different types; Noninflammatory; Osteoarthritis, N...