Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115310
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2005-06-21
Brief Title:
Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Sponsor:
NeurogesX
Organization:
NeurogesX
Study Overview
Official Title:
A Randomized Double-Blind Controlled 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 to assess the efficacy and safety of NGX-4010 applied for 60 minutes for the treatment of postherpetic neuralgia PHN
Detailed Description:
This study is a 12-week randomized double-blind controlled multi-center evaluation of the efficacy safety and tolerability of NGX-4010 for the treatment of PHN Eligible subjects will have moderate to severe pain from PHN with average NPRS scores during screening of 3 to 9 inclusive Painful areas of up to 1000 square centimeters will be treated during a single treatment administration in this study Subjects will be randomly assigned to receive active NGX-4010 patches or low-concentration control patches that are identical in appearance according to a 11 allocation scheme
Subjects may be on stable chronic oral pain medication regimens but currently will not be using any topical pain medications on the affected areas NPRS scores for the average pain in the past 24 hours will be recorded daily in the evening beginning on the day of the Screening Visit usually on Day -14 Subjects will continue to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12 Subjects will return for interim follow-up visits at Weeks 4 and 8 following study treatment
Subjects may be on stable chronic oral pain medication regimens but currently will not be using any topical pain medications on the affected areas NPRS scores for the average pain in the past 24 hours will be recorded daily in the evening beginning on the day of the Screening Visit usually on Day -14 Subjects will continue to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12 Subjects will return for interim follow-up visits at Weeks 4 and 8 following study 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