Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-28 @ 11:44 PM
Study NCT ID:
NCT02495857
Status:
COMPLETED
Last Update Posted:
2020-06-23
First Post:
2015-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
Sponsor:
Actavis Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Study of the Effectiveness and Safety of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2020-06
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 study is a prospective, multi-center, randomized, three-arm, parallel group, clinical study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of Investigational hyaluronate as compared to placebo injected into the target knee for the treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the investigational product will also be compared with Euflexxa.
Detailed Description:
The primary objective is to evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of hyaluronate viscosupplement as compared to placebo injected into the target knee for the treatment of pain in subjects with OA As secondary objectives, the study will evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of Viscosupplement as compared to Euflexxa injected into the target knee for the treatment of pain in subjects with OA. In addition, to assess the effect of Viscosupplement on pain, stiffness, and physical function of the target knee, as well as functional health and general well-being
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?: