Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131352
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2005-08-17
Brief Title:
A Study of the Safety and Efficacy of Hylan G-F 20 Synvisc in Patients With Symptomatic Osteoarthritis of the Knee
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multi-Centre Parallel Double-Blind Blinded Evaluator Randomised Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical study is to evaluate the safety and efficacy of hylan G-F 20 Synvisc in patients with symptomatic knee osteoarthritis OA Patients will be given 6 mL of hylan G-F 20 Synvisc or a phosphate buffered saline control with a possible repeat treatment with Synvisc after the week 26 visit
Detailed Description:
The trial included an initial 26 week treatment with 6 mL of hylan G-F 20 Synvisc or a phosphate buffered saline control followed by a 4 week repeat treatment of Synvisc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None