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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.
J Acquir Immune Defic Syndr. 2012 Feb 01; 59(2):126-33.JA

Abstract

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.

Authors+Show Affiliations

Department of Neurology, Washington University School of Medicine, St. Louis, MO 63110, USA. cliffordd@neuro.wustl.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22067661

Citation

Clifford, David B., et al. "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 of Acquired Immune Deficiency Syndromes (1999), vol. 59, no. 2, 2012, pp. 126-33.
Clifford DB, Simpson DM, Brown S, et al. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr. 2012;59(2):126-33.
Clifford, D. B., Simpson, D. M., Brown, S., Moyle, G., Brew, B. J., Conway, B., Tobias, J. K., & Vanhove, G. F. (2012). 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 of Acquired Immune Deficiency Syndromes (1999), 59(2), 126-33. https://doi.org/10.1097/QAI.0b013e31823e31f7
Clifford DB, et al. A Randomized, Double-blind, Controlled Study of NGX-4010, a Capsaicin 8% Dermal Patch, for the Treatment of Painful HIV-associated Distal Sensory Polyneuropathy. J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):126-33. PubMed PMID: 22067661.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. AU - Clifford,David B, AU - Simpson,David M, AU - Brown,Stephen, AU - Moyle,Graeme, AU - Brew,Bruce J, AU - Conway,Brian, AU - Tobias,Jeffrey K, AU - Vanhove,Geertrui F, AU - ,, PY - 2011/11/10/entrez PY - 2011/11/10/pubmed PY - 2012/3/9/medline SP - 126 EP - 33 JF - Journal of acquired immune deficiency syndromes (1999) JO - J Acquir Immune Defic Syndr VL - 59 IS - 2 N2 - 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. SN - 1944-7884 UR - https://www.unboundmedicine.com/medline/citation/22067661/A_randomized_double_blind_controlled_study_of_NGX_4010_a_capsaicin_8_dermal_patch_for_the_treatment_of_painful_HIV_associated_distal_sensory_polyneuropathy_ L2 - https://doi.org/10.1097/QAI.0b013e31823e31f7 DB - PRIME DP - Unbound Medicine ER -