Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233155
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2005-10-03
Brief Title:
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy HIV-AN or Postherpetic Neuralgia PHN
Sponsor:
NeurogesX
Organization:
NeurogesX
Study Overview
Official Title:
A Multicenter Open-Label Phase 2 Study of NGX-4010 for the Treatment of Neuropathic Pain in Patients With Painful HIV-Associated Neuropathy HIV-AN or Postherpetic Neuralgia PHN
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 evaluate the safety and efficacy of NGX-4010 administered at intervals of no less than 12 weeks over 1 year based on the presence or return of pain for the treatment of painful HIV-AN and PHN Participation is limited to former study subjects from previous trials of NGX-4010 at selected sites
Detailed Description:
Study C118 is a multicenter open-label single-arm study for subjects who successfully completed a previous NGX-4010 study and have not received open-label or blinded NGX-4010 study patches within the 12 weeks prior to study entry One hundred eligible subjects will receive an initial open-label NGX-4010 study patch application and up to three additional open-label NGX-4010 applications at intervals of no less than 12 weeks based on the presence or return of pain Eligible subjects will have moderate to severe neuropathic pain secondary to HIV-AN or PHN with average pain levels deemed appropriate for further treatment with NGX-4010 as judged by the Investigator
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