Viewing Study NCT00064623



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Study NCT ID: NCT00064623
Status: COMPLETED
Last Update Posted: 2008-03-06
First Post: 2003-07-10

Brief Title: Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
Sponsor: NeurogesX
Organization: NeurogesX

Study Overview

Official Title: A Randomized Double-Blind Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy
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 determine if an investigational drug NGX-4010 high-concentration capsaicin patch is effective in treating painful HIV-associated neuropathy
Detailed Description: The C107 study is a randomized double-blind controlled dose finding study of NGX-4010 for the treatment of painful symptoms of HIV-associated neuropathy Participants will be randomly assigned to receive initial treatment according to one of three doses application durations and to receive double-blind NGX-4010 patch high-concentration capsaicin or matching control low-concentration capsaicin

Participants who complete study evaluations through Week 12 will have the option of receiving up to 3 additional open-label treatments

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