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A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia.
J Pain. 2010 Oct; 11(10):972-82.JP

Abstract

Postherpetic neuralgia (PHN) is a painful complication of acute herpes zoster. This multicenter, double-blind, controlled study randomized 299 PHN patients to receive either NGX-4010, a high-concentration capsaicin (8%) patch, or a low-concentration capsaicin (0.04%) control patch for 30, 60, or 90 minutes. The mean percent reductions in NPRS score from baseline to weeks 2 through 8 were significantly greater in the total NGX-4010 group (26.5%, P = .0286) and the 90-minute NGX-4010 group (27.8%, P = .0438) compared to the pooled control group (17.3%). After review of the data suggested a difference between genders in reporting of pain scores and a higher proportion of males (61%) in the 60-minute NGX-4010 group, post hoc gender-stratified analyses were performed and showed that the 60-minute NGX-4010 group also had a significantly larger mean percent reduction in average pain scores (28.0%, P = .0331). Pain reduction in the 30-minute NGX-4010 group, although similar in magnitude to the other doses, was not significantly different from control in either of these analyses. Similar results were observed during weeks 2 through 12. Most treatment-emergent adverse events were application-site specific, transient and mostly mild to moderate in severity.

PERSPECTIVE

This article reports the safety and efficacy of NGX-4010 applied for 3 different durations (30, 60, or 90 minutes) in patients with PHN. The results identified the 60-minute duration as the dose to be evaluated in subsequent studies and identified a gender effect on reported changes in pain.

Authors+Show Affiliations

Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah 84106, USA. lynnw@lifetreeresearch.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20655809

Citation

Webster, Lynn R., et al. "A Multicenter, Randomized, Double-blind, Controlled Dose Finding Study of NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia." The Journal of Pain : Official Journal of the American Pain Society, vol. 11, no. 10, 2010, pp. 972-82.
Webster LR, Malan TP, Tuchman MM, et al. A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. J Pain. 2010;11(10):972-82.
Webster, L. R., Malan, T. P., Tuchman, M. M., Mollen, M. D., Tobias, J. K., & Vanhove, G. F. (2010). A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. The Journal of Pain : Official Journal of the American Pain Society, 11(10), 972-82. https://doi.org/10.1016/j.jpain.2010.01.270
Webster LR, et al. A Multicenter, Randomized, Double-blind, Controlled Dose Finding Study of NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia. J Pain. 2010;11(10):972-82. PubMed PMID: 20655809.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. AU - Webster,Lynn R, AU - Malan,T Philip, AU - Tuchman,Michael M, AU - Mollen,Martin D, AU - Tobias,Jeffrey K, AU - Vanhove,Geertrui F, Y1 - 2010/07/24/ PY - 2009/09/22/received PY - 2009/12/21/revised PY - 2010/01/15/accepted PY - 2010/7/27/entrez PY - 2010/7/27/pubmed PY - 2011/7/20/medline SP - 972 EP - 82 JF - The journal of pain : official journal of the American Pain Society JO - J Pain VL - 11 IS - 10 N2 - UNLABELLED: Postherpetic neuralgia (PHN) is a painful complication of acute herpes zoster. This multicenter, double-blind, controlled study randomized 299 PHN patients to receive either NGX-4010, a high-concentration capsaicin (8%) patch, or a low-concentration capsaicin (0.04%) control patch for 30, 60, or 90 minutes. The mean percent reductions in NPRS score from baseline to weeks 2 through 8 were significantly greater in the total NGX-4010 group (26.5%, P = .0286) and the 90-minute NGX-4010 group (27.8%, P = .0438) compared to the pooled control group (17.3%). After review of the data suggested a difference between genders in reporting of pain scores and a higher proportion of males (61%) in the 60-minute NGX-4010 group, post hoc gender-stratified analyses were performed and showed that the 60-minute NGX-4010 group also had a significantly larger mean percent reduction in average pain scores (28.0%, P = .0331). Pain reduction in the 30-minute NGX-4010 group, although similar in magnitude to the other doses, was not significantly different from control in either of these analyses. Similar results were observed during weeks 2 through 12. Most treatment-emergent adverse events were application-site specific, transient and mostly mild to moderate in severity. PERSPECTIVE: This article reports the safety and efficacy of NGX-4010 applied for 3 different durations (30, 60, or 90 minutes) in patients with PHN. The results identified the 60-minute duration as the dose to be evaluated in subsequent studies and identified a gender effect on reported changes in pain. SN - 1528-8447 UR - https://www.unboundmedicine.com/medline/citation/20655809/A_multicenter_randomized_double_blind_controlled_dose_finding_study_of_NGX_4010_a_high_concentration_capsaicin_patch_for_the_treatment_of_postherpetic_neuralgia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1526-5900(10)00296-8 DB - PRIME DP - Unbound Medicine ER -