Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 10:30 PM
Study NCT ID:
NCT04640961
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2020-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint
Sponsor:
Anika Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Shoulder Joint
Status:
COMPLETED
Status Verified Date:
2024-12
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 Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the shoulder joint.
Detailed Description:
Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH). Participants to be followed to 6 Months post-injection.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: