Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399042
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj as Compared to Synovian Inj in Patients With Mild to Moderate Knee Osteoarthritis
Sponsor:
Shin Poong Pharmaceutical Co Ltd
Organization:
Shin Poong Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multi-center Randomized Double-Blinded Active Controlled Phase III Study to Evaluate Efficacy and Safety of SP5M002 Injection Compared With Synovian Injection in Patients With Mild to Moderate Knee Osteoarthritis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 is a randomized double-blind multicenter Active Controlled pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine HMDA cross-linked hyaluronate intra-articular injection SP5M002 compared with an active comparator the 14-butanediol diglycidyl ether BDDE cross-linked hyaluronate Synovian in patients with knee osteoarthritis
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None