A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)

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

Timeline

Start

2012-03

Primary completion

2013-09

Completion

2013-09

Drugs

Indications