title: A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy.
abstract: BACKGROUND
  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: Department of Neurology, Washington University School of Medicine, St. Louis, MO 63110, USA. cliffordd@neuro.wustl.edu
authors: David B
authors: DB
authors: Clifford
authors: David M
authors: DM
authors: Simpson
authors: Stephen
authors: S
authors: Brown
authors: Graeme
authors: G
authors: Moyle
authors: Bruce J
authors: BJ
authors: Brew
authors: Brian
authors: B
authors: Conway
authors: Jeffrey K
authors: JK
authors: Tobias
authors: Geertrui F
authors: GF
authors: Vanhove
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000982:Antipruritics / Q000627:therapeutic use*; D002211:Capsaicin / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005534:Foot Diseases / Q000188:drug therapy*; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D010147:Pain Measurement; D011115:Polyneuropathies / Q000188:drug therapy*
chemical_list: D018712:Analgesics, Non-Narcotic; D000982:Antipruritics; D002211:Capsaicin