A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee; Musculoskeletal Diseases
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Musculoskeletal Diseases
Intervention: hylan G-F 20; Phosphate Buffered Saline
Intervention description: Single injection of 6 mL of hylan G-F 20 (Synvisc).; Single injection of 6 mL phosphate buffered saline.
Intervention MeSH terms: Hylan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis of the knee; Musculoskeletal

Summary:

      This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in
      patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F
      20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with
      Synvisc after the week 26 visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with documented diagnosis of primary osteoarthritis (OA) of the target knee
             made at least 3 months prior to Screening,

          -  Has radiographic evidence of OA in the tibio-femoral compartment of the target, knee
             with at least 1 definite osteophyte and a measureable joint space, as diagnosed by
             standard X-rays taken not longer than 3 months prior to Screening, and before any
             baseline assessment,

          -  Has continued target knee pain despite conservative treatment (e.g. weight reduction,
             physical therapy, analgesics),

          -  Has pain in the target knee as demonstrated by a score of 2 or 3 on the Western
             Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC
             LK 3.1) A1 (Walking Pain) Subscale ,

          -  Has a mean score of 1.5 to 3.5 on the Western Ontario and McMaster Universities
             Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale.

          -  Inclusion Criteria for Repeat Phase: Must have no major safety concerns during the
             first course of treatment as assessed by the Investigator; Must have a WOMAC LK 3.1 A
             score of at least 1.

        Exclusion criteria:

          -  Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the
             patello-femoral compartment of the target knee confirmed by standard X-rays taken not
             longer than 3 months prior to Screening, and before any baseline assessment,

          -  Has clinically apparent tense effusion of the target knee,

          -  Has had viscosupplementation in any joint including the target knee within 9 months
             prior to Screening,

          -  Has concomitant inflammatory disease or other condition that affects the joints (e.g.
             rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic
             chondrocalcinosis and active infection, etc.,)

          -  Symptomatic OA of the contralateral knee or of either hip that is not responsive to
             paracetamol and requires other therapy,

          -  Has related hypersensitivities to avian proteins and/or any components of
             hyaluronan-based injection devices,