Parameter | Capsaicin 8% patch (30 min) + SOC (n = 156) | Capsaicin 8% patch (60 min) + SOC (n = 157) | SOC (n = 155) |
---|---|---|---|
Sex, n (%) | |||
Male | 74 (47.4) | 79 (50.3) | 71 (45.8) |
Female | 82 (52.6) | 78 (49.7) | 84 (54.2) |
Ethnicity, n (%) | |||
Caucasian | 154 (98.7) | 155 (98.7) | 154 (99.4) |
Other | 2 (1.3) | 2 (1.3) | 1 (0.6) |
Age, years | |||
Mean [SD] | 60.9 [10.9] | 61.0 [10.3] | 59.1 [10.3] |
Weight, kg | |||
Mean [SD] | 86.6 [14.5] | 86.7 [16.4] | 89.6 [17.6] |
Height, cm | |||
Mean [SD] | 169.7 [8.9] | 169.7 [9.0] | 169.3 [10.9] |
Body mass index, kg/m2 | |||
Mean [SD] | 30.1 [4.6] | 30.1 [5.0] | 31.2 [5.0] |
Duration of PDPN, years | |||
Mean [SD] | 4.1 [3.7] | 4.4 [3.9] | 4.4 [3.6] |
Pain medications before baseline, n (%) | |||
Overall | 70 (44.9) | 71 (45.2) | 79 (51.0) |
Analgesicsa | 56 (35.9) | 54 (34.4) | 59 (38.1) |
Antiepileptics | 44 (28.2) | 49 (31.2) | 52 (33.5) |
Psycholeptics | 22 (14.1) | 19 (12.1) | 24 (15.5) |
Anti-inflammatory/antirheumatic products | 14 (9.0) | 12 (7.6) | 17 (11.0) |
Topical joint/muscular pain productsb | 14 (9.0) | 11 (7.0) | 15 (9.7) |
Baseline average pain score (BPI-DN question 5) | |||
Mean [SD] | 5.6 [1.3] | 5.6 [1.4] | 5.5 [1.3] |
Baseline Norfolk QOL-DN score | |||
Mean [SD] | 42.8 [19.5] | 40.6 [18.3] | 41.0 [18.5] |
Baseline UENS total score | |||
Mean [SD] | 17.0 [7.4] | 16.5 [7.0] | 15.6 [6.2] |
HbA1c at screening | |||
Mean, % [SD] | 7.3 [1.0] | 7.4 [1.0] | 7.4 [1.0] |
Mean, mmol/mol [SD] | 56.6 [10.8] | 57.5 [10.8] | 57.6 [11.4] |