Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT03191903
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide
Sponsor:
Anika Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal™) to Provide Symptomatic Relief of Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2022-02
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 is a multi-center, randomized, double-blind, parallel group, active comparator controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the relief of joint pain in subjects with OA of the knee.
Detailed Description:
Cingal 16-02 is a multi-center, randomized, double-blind, active comparator controlled study designed to evaluate the relative contributions of the individual constituents (Hyaluronic Acid and Triamcinolone Hexacetonide) in the Cingal combination product to pain relief as measured by the change in WOMAC Pain from baseline through 26 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: