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A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy

journal contribution
posted on 2023-06-08, 16:22 authored by David B Clifford, David M Simpson, Stephen Brown, Graeme Moyle, Bruce J Brew, Brian Conway, Jeffrey K Tobias, Geertrui F Vanhove, Martin Fisher, for the NGX-4010 C119 Study Group
INTRODUCTION Effective treatment of HIV-associated distal sensory polyneuropathy remains a significant unmet therapeutic need. METHODS In this randomized, double-blind, controlled study, patients with pain due to HIV-associated distal sensory polyneuropathy received a single 30-minute or 60-minute application of NGX-4010--a capsaicin 8% patch (n = 332)--or a low-dose capsaicin (0.04%) control patch (n = 162). The primary endpoint was the mean percent change from baseline in Numeric Pain Rating Scale score to weeks 2-12. Secondary endpoints included patient global impression of change at week 12. RESULTS Pain reduction was not significantly different between the total NGX-4010 group (-29.5%) and the total control group (-24.5%; P = 0.097). Greater pain reduction in the 60-minute (-30.0%) versus the 30-minute control group (-19.1%) prevented intended pooling of the control groups to test individual NGX-4010 treatment groups. No significant pain reduction was observed for the 30-minute NGX-4010 group compared with 30-minute control (-26.2% vs.-19.1%, respectively, P = 0.103). Pain reductions in the 60-minute NGX-4010 and control groups were comparable (-32.8% vs. -30.0%, respectively; P = 0.488). Posthoc nonparametric testing demonstrated significant differences favoring the total (P = 0.044) and 30-minute NGX-4010 groups (P = 0.035). Significantly, more patients in the total and 30-minute NGX-4010 group felt improved on the patient global impression of change versus control (67% vs. 55%, P = 0.011 and 65% vs. 45%, P = 0.006, respectively). Mild to moderate transient application site pain and erythema were the most common adverse events. CONCLUSIONS Although the primary endpoint analyses were not significant, trends toward pain improvement were observed after a single 30-minute NGX-4010 treatment.

History

Publication status

  • Published

Journal

JAIDS Journal of Acquired Immune Deficiency Syndromes

ISSN

1944-7884

Publisher

Wolters Kluwer

Issue

2

Volume

59

Page range

126-133

Department affiliated with

  • BSMS Publications

Notes

Martin Fisher is part of the NGX-4010 C119 Study Group and not one of the principal authors

Full text available

  • No

Peer reviewed?

  • Yes

Legacy Posted Date

2013-12-23

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