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

NCT01586338 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2016-02-24

Study results available
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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

Conditions

Interventions

DRUG

Hylan G-F 20

Intra-articular injection (pre-filled glass syringe)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586338 on ClinicalTrials.gov