| 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 | — | — | — |