Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-30 @ 8:51 PM
Study NCT ID:
NCT01265459
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2010-12-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Different Volumes of Durolane in Knee OA
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2014-03
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:
The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.
Detailed Description:
To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.
Study Oversight
Has Oversight DMC:
False
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?: