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Table 3 Integrated efficacy data for the 30- and 60-minute treatment groups

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 = 100) (n = 115)
LS mean change (SE) in NPRS score from baseline to Weeks 2–12 −27.4 (1.4) −26.9 (2.1) −27.9 (2.0) −20.0 (2.1) −15.8 (3.0) −24.2 (2.9)
95% CI of LS mean −30.1, –24.7 −30.8, –23.0 −31.7, –24.0 −24.1, –15.9 −21.8, –9.8 −29.8, –18.6
p-value* 0.0034 0.0024 0.2935
Patients with ≥30% reduction in NPRS score from baseline to Weeks 2–12, n (%) 193 (40) 95 (40) 98 (40) 66 (31) 23 (23) 43 (37)
OR 1.65 2.21 1.22
95% CI of OR 1.15, 2.35 1.29, 3.79 0.77, 1.95
p-value 0.0062 0.0040 0.3949
PGIC at Week 12 n = 438 n = 220 n = 218 n = 196 n = 92 n = 104
Very much/much/slightly improved, n (%) 294 (67) 143 (65) 151 (69) 97 (49) 38 (41) 59 (57)
p-value <0.0001 0.0001 0.0333
  1. CI confidence interval, LS least square, NPRS Numeric Pain Rating Scale, OR odds ratio, PGIC Patient Global Impression of Change, SE standard error.
  2. *p-value is computed using weighted gender-stratified ANCOVA to test for difference between each NGX-4010 group and the respective control group, with baseline pain, pre-topical anesthetic pain, and percent change in pain during topical anesthetic application as covariates.
  3. p-value is computed using logistic regression to test for difference between each NGX-4010 group and the respective control group, with gender, baseline pain, pre-topical anesthetic pain, and percent change in pain as covariates.
  4. p-values were computed using Fisher’s exact test comparing each NGX-4010 group and the respective control group.