A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
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