Ignite Creation Date:
2024-05-06 @ 3:37 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02332148
Status:
UNKNOWN
Last Update Posted:
2015-08-21
First Post:
2015-01-05
Brief Title:
Assessment of the Safety and Efficacy of 3VM1001 Cream for Treatment of Chronic Pain Caused by Knee Osteoarthritis
Sponsor:
CDA Research Group Inc
Organization:
CDA Research Group Inc
Study Overview
Official Title:
A Double-blind Placebo-controlled Randomized Study to Assess the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee A Proof of Concept Study
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
NOT_YET_RECRUITING
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:
3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee This proof of concept study is a randomized placebo-controlled double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo Subjects will self-treat for 30 days
Detailed Description:
3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee This proof of concept study is a randomized placebo-controlled double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo Subjects will self-treat for 30 days with investigational drug or placebo Rescue medication with acetaminophen up to 2g daily is permitted This study is intended to evaluate the safety and efficacy of 3VM1001 topical cream a copper-containing cream Subjects will self treat with drug or placebo three times daily for 30 days All subjects will have a total of three visits to the clinic and will complete a daily diary each day for the 30 days of treatment
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