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A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia.Pain Med. 2011 Jan; 12(1):99-109.PM
Abstract
OBJECTIVES
To confirm the efficacy, tolerability, and safety of NGX-4010, an 8% capsaicin dermal patch (capsaicin 640 µg/cm(2)), in patients with postherpetic neuralgia (PHN). PHN is a chronic pain disorder that can be difficult to treat and for which current treatment options are often limited by poor tolerability.
DESIGN
A total of 418 patients were randomized to receive a single 60-minute application of NGX-4010 or a 0.04% capsaicin control patch (3.2 µg/cm(2)) in a multicenter, double-blind, confirmatory, phase 3 study.
PATIENTS
Patients were 18-90 years old with a diagnosis of PHN, pain for at least 6 months, and an average baseline Numeric Pain Rating Scale (NPRS) score of 3-9.
OUTCOME MEASURES
The primary efficacy end point was the percentage change in NPRS score from baseline to weeks 2-8.
RESULTS
NGX-4010 recipients had a significantly greater mean reduction from baseline in pain during weeks 2-8 compared with the control group (32.0% vs 24.4%; P=0.011). A ≥ 30% reduction in mean NPRS scores was achieved in 46% of NGX-4010 recipients compared with 34% of controls (P=0.02). Pain was significantly lower in NGX-4010 recipients than controls by week 2, and greater pain reduction was maintained throughout the remaining 12-week study period. Most treatment-emergent adverse events were application site specific (notably erythema and pain), transient, and generally mild to moderate in severity.
CONCLUSIONS
In patients with PHN, a single 60-minute application of NGX-4010 produced significant reduction in pain that was maintained over a 12-week period.
Links
MeSH
Pub Type(s)
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Language
eng
PubMed ID
21087403
Clinical Trial Links
Citation
Irving, Gordon A., et al. "A Multicenter, Randomized, Double-blind, Controlled Study of NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia." Pain Medicine (Malden, Mass.), vol. 12, no. 1, 2011, pp. 99-109.
Irving GA, Backonja MM, Dunteman E, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med. 2011;12(1):99-109.
Irving, G. A., Backonja, M. M., Dunteman, E., Blonsky, E. R., Vanhove, G. F., Lu, S. P., & Tobias, J. (2011). A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Medicine (Malden, Mass.), 12(1), 99-109. https://doi.org/10.1111/j.1526-4637.2010.01004.x
Irving GA, et al. A Multicenter, Randomized, Double-blind, Controlled Study of NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia. Pain Med. 2011;12(1):99-109. PubMed PMID: 21087403.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR
T1 - A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia.
AU - Irving,Gordon A,
AU - Backonja,Miroslav M,
AU - Dunteman,Edwin,
AU - Blonsky,E Richard,
AU - Vanhove,Geertrui F,
AU - Lu,Shiao-Ping,
AU - Tobias,Jeffrey,
AU - ,,
Y1 - 2010/11/18/
PY - 2010/11/20/entrez
PY - 2010/11/23/pubmed
PY - 2011/5/5/medline
SP - 99
EP - 109
JF - Pain medicine (Malden, Mass.)
JO - Pain Med
VL - 12
IS - 1
N2 - OBJECTIVES: To confirm the efficacy, tolerability, and safety of NGX-4010, an 8% capsaicin dermal patch (capsaicin 640 µg/cm(2)), in patients with postherpetic neuralgia (PHN). PHN is a chronic pain disorder that can be difficult to treat and for which current treatment options are often limited by poor tolerability. DESIGN: A total of 418 patients were randomized to receive a single 60-minute application of NGX-4010 or a 0.04% capsaicin control patch (3.2 µg/cm(2)) in a multicenter, double-blind, confirmatory, phase 3 study. PATIENTS: Patients were 18-90 years old with a diagnosis of PHN, pain for at least 6 months, and an average baseline Numeric Pain Rating Scale (NPRS) score of 3-9. OUTCOME MEASURES: The primary efficacy end point was the percentage change in NPRS score from baseline to weeks 2-8. RESULTS: NGX-4010 recipients had a significantly greater mean reduction from baseline in pain during weeks 2-8 compared with the control group (32.0% vs 24.4%; P=0.011). A ≥ 30% reduction in mean NPRS scores was achieved in 46% of NGX-4010 recipients compared with 34% of controls (P=0.02). Pain was significantly lower in NGX-4010 recipients than controls by week 2, and greater pain reduction was maintained throughout the remaining 12-week study period. Most treatment-emergent adverse events were application site specific (notably erythema and pain), transient, and generally mild to moderate in severity. CONCLUSIONS: In patients with PHN, a single 60-minute application of NGX-4010 produced significant reduction in pain that was maintained over a 12-week period.
SN - 1526-4637
UR - https://www.unboundmedicine.com/medline/citation/21087403/A_multicenter_randomized_double_blind_controlled_study_of_NGX_4010_a_high_concentration_capsaicin_patch_for_the_treatment_of_postherpetic_neuralgia_
L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2010.01004.x
DB - PRIME
DP - Unbound Medicine
ER -
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