
NGX4010

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 pretopical 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)

pvalue^{†}

<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)

pvalue^{‡}

0.1340

0.2912

0.2872

—

—

—

Patients using medication for treatmentrelated discomfort on Days 0–5, n (%)

342 (71)

162 (68)

180 (74)

67 (31)

29 (29)

38 (33)

pvalue^{§}

<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)

pvalue**

<0.0001

0.001

<0.0001

—

—

—

 NPRS Numeric Pain Rating Scale, SD standard deviation.
 *Includes the evening of the treatment day.
 ^{†} pvalue was computed using a Wilcoxon ranksum test comparing the means between each NGX4010 group and the pooled control group.
 ^{‡} pvalue was computed using a Pearson’s chisquare test comparing the percentages of patients between each NGX4010 group and the pooled control group.
 ^{§} pvalue was computed using a Fisher’s exact test comparing the percentages of patients between each NGX4010 group and the pooled control group.
 ^{‖}Dermal irritation assessed by scoring the irritation from 0–7 where 0=no evidence of irritation, 1=minimal erythema, barely perceptible, 2=definite erythema, readily visible, minimal edema or minimal papular response, 3=erythema and papules, 4=definite edema, 5=erythema, edema, and papules, 6=vesicular eruption, and 7=strong reaction spreading beyond test [24].
 ** pvalue was computed using an exact Cochran–Mantel–Haenszel test comparing the distribution of scores between each NGX4010 group and the pooled control group.