Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000410
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-08-14
Brief Title:
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
Sponsor:
Organogenesis
Organization:
Organogenesis
Study Overview
Official Title:
A Phase 3 Prospective Multicenter Double-blind Randomized Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft ASA in Patients With Osteoarthritis of the Knee
Status:
RECRUITING
Status Verified Date:
2024-02
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 study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis OA symptoms of the knee
Detailed Description:
This is a prospective multicenter randomized double-blind placebo-controlled Phase 3 study of ASA in patients with OA of the knee Initially 474 subjects are planned for inclusion in this study using a group sequential design with an interim analyses and a final analysis Patients will be randomly assigned in a 11 ratio to receive a single intra-articular IA injection of 2 mL of ASA plus 2 mL of normal saline or 4 mL of normal saline on Day 1
They will have serial assessments of knee pain function and symptoms scores as well as safety assessments for up to 52 weeks after administration of the study drug
They will have serial assessments of knee pain function and symptoms scores as well as safety assessments for up to 52 weeks after administration of the study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None