A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee

FX006-2011-001

The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.

2012-06-01

2013-04-01

2013-04-01

Completed

Early phase I

229

Main Inclusion Criteria: * Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions * Male or female \>=40 years of age * Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period * Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) * Body mass index (BMI) ≤ 40 kg/m2 * Willingness to abstain from use of restricted medications Main Exclusion Criteria * Ipsilateral hip OA * Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee * History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis * History of arthritides due to crystals (e.g., gout, pseudogout) * History of infection in the index joint * Clinical signs and symptoms of active knee infection or crystal disease of the index knee * Presence of surgical hardware or other foreign body in the index knee * Unstable joint (such as a torn anterior cruciate ligament) * IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening * IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening * Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening * Prior arthroscopic or open surgery of the index knee within 12 months of Screening * Planned/anticipated surgery of the index knee during the study period * Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ * Insulin-dependent diabetes * Active psychiatric disorder including psychosis and major depressive disorder * History of or active Cushing's syndrome * Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes) * Skin breakdown at the knee where the injection would take place * Women of child-bearing potential not using effective contraception or who are pregnant or nursing

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2024-01-24