Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain
| Autor: | Biao Lu, Geertrui F. Vanhove, Frederick T. Murphy, Jeffrey Tobias, John F. Peppin, Lynn R. Webster |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Drug-Related Side Effects and Adverse Reactions Lidocaine Transdermal patch Endocrinology Diabetes and Metabolism Neuralgia Postherpetic Pain Transdermal Patch Polyneuropathies Endocrinology Diabetic Neuropathies Diabetes mellitus Internal Medicine medicine Humans Anesthetics Local Adverse effect Aged Postherpetic neuralgia business.industry Peripheral Nervous System Diseases General Medicine Middle Aged medicine.disease Clinical trial Treatment Outcome Tolerability Anesthesia Sensory System Agents Neuralgia Female Capsaicin business medicine.drug |
| Zdroj: | Diabetes Research and Clinical Practice. 93:187-197 |
| ISSN: | 0168-8227 |
| DOI: | 10.1016/j.diabres.2011.04.010 |
| Popis: | Aims To assess efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in patients with peripheral neuropathic pain. Methods This open-label, uncontrolled, 12-week study enrolled 25 patients with postherpetic neuralgia (PHN), one with HIV-distal sensory polyneuropathy, and 91 with painful diabetic neuropathy (PDN). Patients received pre-treatment with one of three 4% lidocaine topical anesthetics (L.M.X.4 1 1L.M.X.4 is a registered trade name of Ferndale Laboratories, Inc., Ferndale, MI, USA., Topicaine Gel 2 2Topicaine is a registered trade name of Estela Basso, Jupiter, FL, USA., or Betacaine Enhanced Gel 4 3 3Betacaine is a cancelled registered trade name of Tiberius, Inc., Tampa, FL, USA.) followed by a single 60- or 90-min NGX-4010 application. The primary efficacy variable was the percentage change in Numeric Pain Rating Scale scores from baseline to Weeks 2–12. Adverse events (AEs), laboratory parameters, vital signs, neurosensory examinations, dermal assessments, treatment-related pain scores, and medication use for treatment-related pain were collected. Results PDN and PHN patients achieved a 31% and 28% mean pain decrease from baseline during Weeks 2–12, respectively, and 47% and 44%, respectively, were responders (≥30% pain decrease). Mild or moderate treatment-site-related burning and pain were the most common AEs and there was no evidence of impaired neurosensory function. Conclusions NGX-4010 in conjunction with any of the three topical anesthetics tested was generally safe and well tolerated and reduced pain over a 12-week period in patients with PDN and PHN. |
| Databáze: | OpenAIRE |
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