Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

2014-07-23 22:00:36 | BioPortfolio


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).

Study Design

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


South Australia




Flexion Therapeutics, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T22:00:36-0400

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PubMed Articles [1648 Associated PubMed Articles listed on BioPortfolio]

Suprachoroidal Space Alterations Following Delivery of Triamcinolone Acetonide: Post-Hoc Analysis of the Phase 1/2 HULK Study of Patients With Diabetic Macular Edema.

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Intralymphatic histiocytosis treated with intralesional triamcinolone acetonide and pressure bandage.

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Medical and Biotech [MESH] Definitions

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.

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