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Table 3 Integrated efficacy data for the 30- and 60-minute treatment groups

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

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

p-value*

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

—

—

—

p-value†

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)

p-value‡

<0.0001

0.0001

0.0333

—

—

—

  1. CI confidence interval, LS least square, NPRS Numeric Pain Rating Scale, OR odds ratio, PGIC Patient Global Impression of Change, SE standard error.
  2. *p-value is computed using weighted gender-stratified ANCOVA to test for difference between each NGX-4010 group and the respective control group, with baseline pain, pre-topical anesthetic pain, and percent change in pain during topical anesthetic application as covariates.
  3. †p-value is computed using logistic regression to test for difference between each NGX-4010 group and the respective control group, with gender, baseline pain, pre-topical anesthetic pain, and percent change in pain as covariates.
  4. ‡p-values were computed using Fisher’s exact test comparing each NGX-4010 group and the respective control group.