Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03421613
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2018-01-30
Brief Title:
3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia PHN
Sponsor:
CDA Research Group Inc
Organization:
CDA Research Group Inc
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Crossover Study to Evaluate the Efficacy and Tolerability of 3VM1001 Cream for the Treatment of Pain Associated With Post-Herpetic Neuralgia A Proof of Concept Study
Status:
COMPLETED
Status Verified Date:
2018-01
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:
PHN
Brief Summary:
Post-herpetic neuralgia PHN is pain following acute herpes zoster defined as pain lasting longer than 3 months Current first line management consists of tricyclic anti-depressants and anti-convulsants such as gabapentin and pregabalin There is an unmet medical need for treatments got topical therapies that demonstrate efficacy without serious side effects
Detailed Description:
Post-herpetic neuralgia PHN is defined as pain following acute herpes zoster AHZ lasting 3 months PHN develops in about 10 of patients following an episode of AHZ 95 of adults ate seropositive for varicella zoster virus antibodies and are therefore at risk for AHZ and PHN Wider use of AHZ vaccine approved in 2006 may reduce the incidence of PHN Nevertheless PHN may be severe and frequently interferes with daily activities and with sleep
First line management of PHN pain currently is tricyclic anti-depressants and anti-convulsants such as gabapentin and pregabalin and use of a 5 lidocaine patch second line therapies include opioid analgesia and topical capsaicin combinations of topical and systemic therapies may be used as well These therapies have common side effects of dry mouth constipation sedation urinary retention nausea somnolence dizziness weight gain and peripheral edema
there is an unmet medial need for topical therapies that demonstrate efficacy without the significant side effects o the therapies mentioned above 3VM cream a low concentration of copper in a cream vehicle may b such a therapy
First line management of PHN pain currently is tricyclic anti-depressants and anti-convulsants such as gabapentin and pregabalin and use of a 5 lidocaine patch second line therapies include opioid analgesia and topical capsaicin combinations of topical and systemic therapies may be used as well These therapies have common side effects of dry mouth constipation sedation urinary retention nausea somnolence dizziness weight gain and peripheral edema
there is an unmet medial need for topical therapies that demonstrate efficacy without the significant side effects o the therapies mentioned above 3VM cream a low concentration of copper in a cream vehicle may b such a therapy
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