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Table 2 Demographic and baseline characteristics from the integrated population of the two phase III HIV-DSP studies

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 NGX-4010   Control Control
NGX-4010 total 30 minutes 60 minutes Control total 30 minutes 60 minutes
(n = 482) (n = 239) (n = 243) (n = 215) (n = 100) (n = 115)
Age, mean (SD), years 49 (8) 50 (9) 49 (8) 50 (8) 49 (8) 50 (9)
Male, n (%) 426 (88) 205 (86) 221 (91) 193 (90) 90 (90) 103 (90)
White, n (%) 315 (65) 156 (65) 159 (65) 144 (67) 68 (68) 76 (66)
Duration of pain, mean (SD), years 5.8 (3.9) 5.6 (3.7) 6.0 (4.1) 5.6 (4.1) 5.9 (3.9) 5.4 (4.4)
Baseline NPRS score, mean (SD) 6.0 (1.6) 6.0 (1.6) 6.0 (1.5) 5.9 (1.5) 6.0 (1.5) 5.8 (1.5)
Receiving concomitant neuropathic pain medication at study entry,* n (%) 339 (70) 180 (75) 159 (65) 143 (67) 72 (72) 71 (62)
Receiving Ntox antiretroviral therapy at baseline, n (%) 52 (11) 25 (10) 27 (11) 18 (8) 8 (8) 10 (9)
CD4 count, mean x106/l (SD) 419 (242) 437 (235) 402 (247) 468 (314) 479 (291) 458 (334)
Viral load, HIV RNA copies/ml, median 400 400 400 400 400 400
(range) (40–5,510,520) (40–610,677) (40–5,510,520) (40–664,583) (40–664,583) (40–460,000)
  1. NPRS Numeric Pain Rating Scale, SD standard deviation.
  2. *A patient was defined as receiving concomitant neuropathic pain medication if he or she was taking an anticonvulsant, non-SSRI antidepressant, or opioid on Day −1 and for a total duration of at least 7 consecutive days.
  3. A patient was defined as receiving antiretroviral therapy if he or she was taking neurotoxic antiretroviral medications for at least 8 weeks prior to the screening date.