Osteoarthritis Clinical Trial
Official title:
A Multicenter, Prospective, Open-label, Single Arm Study of the Efficacy and Safety of Synvisc® (Hylan G-F 20) in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Primary Objective:
- To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score
- To evaluate the safety using the incidence, severity, seriousness, relatedness, and
frequency of all treatment emergent Adverse Events (AEs)
Secondary Objectives:
- To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks
8, and 12
- To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and
26
- To evaluate the change in Patient Global Assessment (PTGA) score between baseline and
weeks 8, 12 and 26
- To evaluate the change in Clinical Observer Global Assessment (COGA) score between
baseline and weeks 8, 12 and 26
- To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and
between baseline and weeks 1, 2, 8, 12 and 26
Duration of study period for each participants was 26-28 weeks. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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