Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-12 @ 10:38 PM
Study NCT ID:
NCT02610504
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Single Center Open Label Study of Shoulder OA Pain
Sponsor:
Bioventus LLC
Organization:
Study Overview
Official Title:
A 26 Week Prospective Open Label Clinical Study Evaluating A Single Intra-Articular Injection of Durolane 3ml for Treatment of Osteoarthritis Pain of the Shoulder
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients
Detailed Description:
Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.
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?: