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Table 1 Summary of randomized, double-blind, controlled trials of NGX-4010 in patients with HIV-DSP

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

Trial Number of patients Dose Mean percent change in NPRS “average pain for past 24 hours” during Weeks 2–12 post application compared with baseline (%)
NGX-4010 Control patch*
C107 [22] 225 82 Single 30-, 60-, or 90-minute application of NGX-4010 patch versus low-concentration (0.04%) capsaicin control patch 30 minutes −27.7
(p = 0.0007versus control)
60 minutes −15.8
(p = 0.291versus control)
90 minutes −24.7
(p = 0.0046versus control)
Pooled −22.8
(p = 0.0026versus control)
C119 [23] 332 162 Single 30- or 60-minute application of NGX-4010 patch versus low-concentration (0.04%) capsaicin control patch 30 minutes −26.2
(p = 0.1031versus control)
60 minutes −32.8
(p = 0.4884versus control)
Pooled −29.5
(p = 0.0967versus control)
  1. NPRS Numeric Pain Rating Score.
  2. *A low-concentration capsaicin patch (0.04% w/w) was used as a control to ensure effective blinding in the randomized studies.
  3. p-value was computed using gender-stratified ANCOVA to test for a difference between the NGX-4010 group and the total control group, with baseline pain score, pre-topical anesthetic pain score, and percent change in pain score after topical anesthetic treatment as covariates.
  4. p-value was computed using a gender-stratified ANCOVA to compare differences between each NGX-4010 group and the respective control group, with baseline pain as the covariate.