Ignite Creation Date:
2024-05-05 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00521989
Status:
TERMINATED
Last Update Posted:
2014-04-29
First Post:
2007-08-27
Brief Title:
CRx-102 Osteoarthritis Multicenter Evaluation Trial
Sponsor:
Zalicus
Organization:
Zalicus
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis and Optional One-Year Extension
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CRx-102-006 study results negative
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMET-1
Brief Summary:
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects
CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA This is the first study to explore the efficacy of CRx-102 in knee OA It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication
CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA This is the first study to explore the efficacy of CRx-102 in knee OA It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication
Detailed Description:
None
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