Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Hylan G-F 20 (GZ402662/SAR402662); Placebo
Intervention description: Pharmaceutical form: Solution for injection
Route of administration: Intra articular; Pharmaceutical form: Solution for injection
Route of administration: Intra articular
Intervention MeSH terms: Hylan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 440.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      -To evaluate the efficacy of a single 6-milliliter (mL) intra-articular (IA) injection of
      Hylan G-F 20 measured by Western Ontario and McMaster Universities Osteoarthritis Index
      (WOMAC) Numerical Rating Scale (NRS) 3.1 A1 score, in comparison to an IA placebo injection
      over 26 weeks, in Chinese participants with symptomatic Osteoarthritis (OA) of the knee.

      Secondary Objectives:

        -  To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by 7-day
           average score of WOMAC A1 pain sub-score in comparison to an IA placebo injection over
           26 weeks.

        -  To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by WOMAC
           A, patient global assessment (PTGA) and clinical observer global assessment (COGA) in
           comparison to an IA placebo injection over 26 weeks.

        -  To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in
           comparison to an IA placebo injection over 26 weeks. Response was defined as WOMAC A1
           greater than or equal to (>=) 2-point improvement from baseline on NRS.

        -  To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20, in comparison to
           an IA placebo injection over 26 weeks.
    

Eligibility criteria:

        Inclusion criteria :

          -  Symptomatic OA of the target knee joint with WOMAC A1 NRS score of >=4.0 and less than
             or equal to (<=) 8.0 as recorded in the baseline period.

          -  Confirmed by standard X-rays performed within 3 months prior to screening visit:
             modified Kellgren-Lawrence Numerical Grading System of Grade I-III in the target knee
             joint.

          -  According to the American College of Rheumatology (ACR) Criteria.

          -  With failure to respond adequately to conservative non-pharmacologic therapy and/or
             simple analgesics, such as acetaminophen.

          -  Participant was willing and was able to provide signed informed consent prior to any
             study related procedures being performed.

        Exclusion criteria:

          -  The score of contralateral knee pain (if present) >3.0 NRS at screening visit.

          -  Ipsilateral hip OA.

          -  Participant with systemic corticosteroids within 12 weeks prior to screening visit.

          -  Participant with injection of IA corticosteroids in the target knee joint within 26
             weeks prior to screening visit.

          -  Concurrent chronic pain conditions with pain score >3.0 NRS at screening, or
             peripheral or central neuropathy that may affect sensation of the target knee area,
             including but not limited to back pain, hip pain, disc herniation, sciatica, diabetic
             neuropathy, post-stroke pain or fibromyalgia.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.