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

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

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 (%)
Trial	NGX-4010	Control patch^*	Dose
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
				30 minutes	(p = 0.0007^†versus control)
				60 minutes	−15.8
				60 minutes	(p = 0.291^†versus control)
				90 minutes	−24.7
				90 minutes	(p = 0.0046^†versus control)
				Pooled	−22.8
				Pooled	(p = 0.0026^†versus 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
				30 minutes	(p = 0.1031^‡versus control)
				60 minutes	−32.8
				60 minutes	(p = 0.4884^‡versus control)
				Pooled	−29.5
				Pooled	(p = 0.0967^‡versus control)

NPRS Numeric Pain Rating Score.
^*A low-concentration capsaicin patch (0.04% w/w) was used as a control to ensure effective blinding in the randomized studies.
^†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.
^‡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.

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