Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee
Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.
Description
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
Conditions
Osteoarthritis of the Knee
Intervention
FX006, commercially available triamcinolone acetonide
Location
Adelaide
South Australia
Australia
Status
Completed
Source
Flexion Therapeutics, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01487200
- Information obtained from ClinicalTrials.gov on December 12, 2012
Medical and Biotech [MESH] Definitions
Triamcinolone Acetonide
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.
Osteoarthritis, Knee
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)
Knee Injuries
Injuries to the knee or the knee joint.
Knee Prosthesis
Replacement for a knee joint.
Arthroplasty, Replacement, Knee
Replacement of the knee joint.
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