Skip to main content

Advertisement

Table 5 Summary of tolerability on the treatment day

From: NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials

  NGX-4010 Control
Total 30 minutes 60 minutes Total 30 minutes 60 minutes
(n = 482) (n = 239) (n = 243) (n = 215) (n = 99) (n = 116)
Change in NPRS score from pre-topical anesthetic time point at the last observation*
 Mean (SD) 1.8 (2.9) 1.5 (3.0) 2.2 (2.8) −0.2 (2.3) −0.1 (2.0) −0.4 (2.5)
 p-value <0.0001 <0.0001 <0.0001
Patients with at least 90% of the intended patch application duration, n (%) 482 (100) 239 (100) 243 (100) 214 (100) 98 (99) 116 (100)
 p-value 0.1340 0.2912 0.2872
Patients using medication for treatment-related discomfort on Days 0–5, n (%) 342 (71) 162 (68) 180 (74) 67 (31) 29 (29) 38 (33)
 p-value§ <0.0001 <0.0001 <0.0001
Maximum dermal irritation score on Day 0, n (%)
 0 198 (41) 111 (46) 87 (36) 121 (56) 56 (57) 65 (56)
 1 135 (28) 66 (28) 69 (28) 69 (32) 33 (33) 36 (31)
 2 133 (28) 58 (24) 75 (31) 24 (11) 10 (10) 14 (12)
 >2 16 (3) 4 (2) 12 (5) 1 (1) 0 (0) 1 (1)
 p-value** <0.0001 0.001 <0.0001
  1. NPRS Numeric Pain Rating Scale, SD standard deviation.
  2. *Includes the evening of the treatment day.
  3. p-value was computed using a Wilcoxon rank-sum test comparing the means between each NGX-4010 group and the pooled control group.
  4. p-value was computed using a Pearson’s chi-square test comparing the percentages of patients between each NGX-4010 group and the pooled control group.
  5. § p-value was computed using a Fisher’s exact test comparing the percentages of patients between each NGX-4010 group and the pooled control group.
  6. Dermal irritation assessed by scoring the irritation from 0–7 where 0=no evidence of irritation, 1=minimal erythema, barely perceptible, 2=definite erythema, readily visible, minimal edema or minimal papular response, 3=erythema and papules, 4=definite edema, 5=erythema, edema, and papules, 6=vesicular eruption, and 7=strong reaction spreading beyond test [24].
  7. ** p-value was computed using an exact Cochran–Mantel–Haenszel test comparing the distribution of scores between each NGX-4010 group and the pooled control group.