Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479687
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2007-05-24
Brief Title:
SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder
Sponsor:
Bioventus LLC
Organization:
Bioventus LLC
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo Controlled Trial of SUPARTZ Sodium Hyaluronate for the Treatment of Chronic Shoulder Pain
Status:
COMPLETED
Status Verified Date:
2021-04
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 clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ sodium hyaluronate compared with phosphate buffered saline PBS for the treatment of glenohumeral osteoarthritis of the shoulder The trial contains two phases Phase I is 26 weeks double blinded and subjects are randomized to either SUPARTZ or PBS treatment Phase II is 26 weeks total 52 weeks and open-label so all subjects will receive SUPARTZ injections only
Detailed Description:
Phase 3 Study Multi-center randomized double blinded two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder
Study Oversight
Has Oversight DMC:
None
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?:
None