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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flexion Therapeutics, Inc.
• Treatments: FX006; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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 >=35 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

• Body mass index (BMI) ≤ 40 kg/m2

• Willingness to abstain from use of the protocol-specified restricted medications

Main Exclusion Criteria:

• 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 or 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

• History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years

• Insulin-dependent diabetes

• 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