Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006 32 mg; Placebo; FX006 16 mg
Intervention description: Single 5 mL IA injection; Single 5 mL IA injection; Single 5 mL IA injection
Intervention MeSH terms: FX006
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee; pain; corticosteroid; intra-articular; injection

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).
    

Eligibility 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