Table 5 Summary of tolerability on the treatment day
NGX-4010 | Control | |||||
|---|---|---|---|---|---|---|
Total | 30 minutes | 60 minutes | Total | 30 minutes | 60 minutes | |
(n = 482) | (n = 239) | (n = 243) | (n = 215) | (n = 99) | (n = 116) | |
Change in NPRS score from pre-topical anesthetic time point at the last observation* | ||||||
 Mean (SD) | 1.8 (2.9) | 1.5 (3.0) | 2.2 (2.8) | −0.2 (2.3) | −0.1 (2.0) | −0.4 (2.5) |
 p-value†| <0.0001 | <0.0001 | <0.0001 | — | — | — |
Patients with at least 90% of the intended patch application duration, n (%) | 482 (100) | 239 (100) | 243 (100) | 214 (100) | 98 (99) | 116 (100) |
 p-value‡ | 0.1340 | 0.2912 | 0.2872 | — | — | — |
Patients using medication for treatment-related discomfort on Days 0–5, n (%) | 342 (71) | 162 (68) | 180 (74) | 67 (31) | 29 (29) | 38 (33) |
 p-value§ | <0.0001 | <0.0001 | <0.0001 | — | — | — |
Maximum dermal irritation‖ score on Day 0, n (%) | ||||||
 0 | 198 (41) | 111 (46) | 87 (36) | 121 (56) | 56 (57) | 65 (56) |
 1 | 135 (28) | 66 (28) | 69 (28) | 69 (32) | 33 (33) | 36 (31) |
 2 | 133 (28) | 58 (24) | 75 (31) | 24 (11) | 10 (10) | 14 (12) |
 >2 | 16 (3) | 4 (2) | 12 (5) | 1 (1) | 0 (0) | 1 (1) |
 p-value** | <0.0001 | 0.001 | <0.0001 | — | — | — |