Abstract | OBJECTIVES: METHODS: Patients recorded their “average pain for the past 24 hours” daily for 12 weeks using an 11-point Numeric Pain Rating Scale (NPRS). Efficacy assessment included the percentage NPRS score reduction from baseline during weeks 2 to 8 and 2 to 12, the proportion of patients responding during weeks 2 to 8 and 2 to 12 and the Patient Global Impression of Change (PGIC) at weeks 8 and 12. RESULTS: During the studies, 302 NGX-4010 and 250 control ( capsaicin, 0.04% wt/wt) patients were using at least 1 systemic neuropathic pain medication; 295 NGX-4010 and 280 control patients were not. During weeks 2 to 8, NGX-4010 patients reported greater reductions in NPRS scores compared with control both in patients using systemic neuropathic pain medications (26.1% vs. 18.1%, P=0.0011) and in patients not using these medications (36.5% vs. 26.2%, P=0.0002). Patients not using systemic neuropathic pain medications reported a greater reduction in pain compared with patients using these medications in both, NGX-4010 and control groups, resulting in comparable treatment differences between NGX-4010 and control regardless of systemic neuropathic pain medication use. Similar results were seen during weeks 2 to 12, for the responder and PGIC analyses. Transient, capsaicin-related application site reactions were the most common adverse events and not affected by systemic neuropathic pain medication use. CONCLUSION: A single 60-minute NGX-4010 treatment reduces PHN for up to 12 weeks regardless of concomitant systemic neuropathic pain medication use.
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Authors | Gordon A Irving, Miroslav Backonja, Richard Rauck, Lynn R Webster, Jeffrey K Tobias, Geertrui F Vanhove |
Journal | The Clinical journal of pain
(Clin J Pain)
Vol. 28
Issue 2
Pg. 101-7
(Feb 2012)
ISSN: 1536-5409 [Electronic] United States |
PMID | 21753727
(Publication Type: Journal Article, Meta-Analysis, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Administration, Cutaneous
- Aged
- Analgesics
(administration & dosage)
- Capsaicin
(administration & dosage)
- Drug Therapy, Combination
(methods)
- Female
- Humans
- Male
- Neuralgia, Postherpetic
(diagnosis, drug therapy, epidemiology)
- Pain Measurement
(drug effects, statistics & numerical data)
- Prevalence
- Risk Assessment
- Risk Factors
- Treatment Outcome
- United States
(epidemiology)
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