Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

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

Details

• Lead Sponsor: Flexion Therapeutics, Inc.
• Treatments: FX006

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 >=40 years of age

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

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

• Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray

• 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 or clinical signs and symptoms of infection in the index joint

• Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)

• Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain

• 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

• Intramuscular (IM) corticosteroids (investigational or marketed) within 3 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

• Women of child-bearing potential not using effective contraception or who are pregnant or nursing