Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006; Placebo; TCA IR 40
Intervention description: Single 5 mL IA injection; Single 5 mL IA injection; Single 1 mL IA injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; FX006; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 486.0
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 safety and efficacy of FX006 for the treatment of
      pain in patients with osteoarthritis of the knee.
    

Eligibility criteria:

        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 symptoms associated with OA of the index knee for 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

          -  Index knee pain for > 15 days over the last month

          -  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

        Exclusion Criteria:

          -  Any condition that could possibly confound the patient's assessment of index knee pain
             in judgement of the investigator (i.e., iIpsilateral hip OA, gout, 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 or greater than
             the index knee pain)

          -  Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
             spondylitis, arthritis associated with inflammatory bowel disease

          -  History of infection in the index knee

          -  Clinical signs and symptoms of active knee infection or crystal disease of the index
             knee within 1 month of Screening

          -  Unstable joint within 12 months of screening

          -  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) or oral corticosteroids (investigational or marketed) within 1
             month 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