Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807529
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2022-12-29
Brief Title:
A Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Symptomatic Knee Osteoarthritis
Sponsor:
Orient Europharma Co Ltd
Organization:
Orient Europharma Co Ltd
Study Overview
Official Title:
A Phase I-II Dose-escalation Double-blinded Placebo-controlled and Dose-finding Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Osteoarthritis of the Knee
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 phase III study aims to evaluate the safety of single doses of 2ccPA 4800 μg and 7200 μg Phase I as well as the safety and efficacy of multiple doses of 2ccPA Phase II in patients with osteoarthritis OA of the knee
Detailed Description:
Osteoarthritis OA is a degenerative disease frequently associated with symptoms such as inflammation stiffness muscle weakness joint swollen and joint pain 2-carba-cyclic phosphatidic acid 2ccPA is the derivative of natural occurring phospholipid mediator cyclic phosphatidic acid cPA Previous studies suggested that 2ccPA inhibits inflammation and may relieve the pain caused by osteoarthritis This phase III study aims to evaluate the safety of single doses of 2ccPA 4800 μg and7200 μg Phase I as well as the safety and efficacy of multiple doses of 2ccPA Phase II in patients with osteoarthritis OA of the knee
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