
NGX4010

Control


Total

30 minutes

60 minutes

Total

30 minutes

60 minutes


(n = 482)

(n = 239)

(n = 243)

(n = 215)

(n = 100)

(n = 115)


LS mean change (SE) in NPRS score from baseline to Weeks 2–12

−27.4 (1.4)

−26.9 (2.1)

−27.9 (2.0)

−20.0 (2.1)

−15.8 (3.0)

−24.2 (2.9)

95% CI of LS mean

−30.1, –24.7

−30.8, –23.0

−31.7, –24.0

−24.1, –15.9

−21.8, –9.8

−29.8, –18.6

pvalue^{*}

0.0034

0.0024

0.2935

—

—

—

Patients with ≥30% reduction in NPRS score from baseline to Weeks 2–12, n (%)

193 (40)

95 (40)

98 (40)

66 (31)

23 (23)

43 (37)

OR

1.65

2.21

1.22

—

—

—

95% CI of OR

1.15, 2.35

1.29, 3.79

0.77, 1.95

—

—

—

pvalue^{†}

0.0062

0.0040

0.3949

—

—

—

PGIC at Week 12

n = 438

n = 220

n = 218

n = 196

n = 92

n = 104

Very much/much/slightly improved, n (%)

294 (67)

143 (65)

151 (69)

97 (49)

38 (41)

59 (57)

pvalue^{‡}

<0.0001

0.0001

0.0333

—

—

—

 CI confidence interval, LS least square, NPRS Numeric Pain Rating Scale, OR odds ratio, PGIC Patient Global Impression of Change, SE standard error.
 ^{*}pvalue is computed using weighted genderstratified ANCOVA to test for difference between each NGX4010 group and the respective control group, with baseline pain, pretopical anesthetic pain, and percent change in pain during topical anesthetic application as covariates.
 ^{†}pvalue is computed using logistic regression to test for difference between each NGX4010 group and the respective control group, with gender, baseline pain, pretopical anesthetic pain, and percent change in pain as covariates.
 ^{‡}pvalues were computed using Fisher’s exact test comparing each NGX4010 group and the respective control group.