Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA 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

Key Inclusion Criteria:

• Written consent to participate in the study

• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions

• Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening

• Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA

• Index knee pain for >15 days over the last month

• Body mass index (BMI) ≤ 40 kg/m2

• Ambulatory and in good general health

Key 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) within 12 months of Screening

• IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening

• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening

• Oral corticosteroids (investigational or marketed) within 1 month of Screening

• Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening

• Any other IA investigational drug/biologic within 6 months of Screening

• Prior use of FX006

• 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