Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061776
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2003-06-03
Brief Title:
NGX-4010 for the Treatment of Postherpetic Neuralgia
Sponsor:
NeurogesX
Organization:
NeurogesX
Study Overview
Official Title:
A Randomized Double-Blind Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is determine if an investigational drug NGX-4010 high-concentration capsaicin dermal patches is effective in treating pain associated with post-herpetic neuralgia PHN
Detailed Description:
Participants will be randomly assigned to receive initial treatment according to one of three doses application durations and will receive either NGX-4010 patch high-concentration capsaicin or matching control low-concentration capsaicin
Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year
Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year
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