Pain Clinical Trial
Official title:
A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
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.
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 and/or
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 (0.04% capsaicin) identical in appearance, at doses (patch
application duration) of either 30 or 60 minutes, according to a 2:1:2:1 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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