Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321672
Status:
COMPLETED
Last Update Posted:
2011-06-14
First Post:
2006-05-02
Brief Title:
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
Sponsor:
NeurogesX
Organization:
NeurogesX
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
Status:
COMPLETED
Status Verified Date:
2011-05
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:
None
Brief Summary:
The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy
Detailed Description:
Study C119 was a multicenter randomized double-blind controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy Eligible subjects had painful HIV-associated neuropathy resulting from HIV disease andor antiretroviral drug exposure in both feet with average numeric pain rating scale NPRS scores during screening of 3 to 9 inclusive Up to four patches covering an area of up to 1120 square centimeters could be used during a single treatment administration in this study Subjects were randomly assigned to receive active NGX-4010 patches 8 capsaicin or low-concentration control patches 004 capsaicin identical in appearance at doses patch application duration of either 30 or 60 minutes according to a 2121 allocation scheme
Subjects could be on stable chronic oral pain medication regimens but could not be using any topical pain medications on the affected areas NPRS scores for the average pain in the past 24 hours were recorded daily in the evening beginning on the day of the Screening Visit usually on Day -14 Subjects continued 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 returned for interim follow-up visits at Weeks 4 and 8 following study treatment
Subjects could be on stable chronic oral pain medication regimens but could not be using any topical pain medications on the affected areas NPRS scores for the average pain in the past 24 hours were recorded daily in the evening beginning on the day of the Screening Visit usually on Day -14 Subjects continued 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 returned 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