NPRS Scores | NGX-4010 (n = 86) | Control (n = 43) | P-value |
---|---|---|---|
Baseline, LS mean (SE) | 5.4 (0.17) | 5.2 (0.24) | Â |
   95% CI | 5.05, 5.72 | 4.77, 5.72 |  |
Change, mean (SE) | Â | Â | Â |
   Baseline to weeks 2 to 8 | -1.8 (0.20) | -1.4 (0.29) | 0.072 |
   95% CI | -2.18, -1.38 | -1.92, -0.79 |  |
   Baseline to weeks 2 to 12 | -1.8 (0.20) | -1.3 (0.28) | 0.160 |
   95% CI | -2.23, -1.44 | -1.90, -0.78 |  |
Percent Change, mean (SE) | Â | Â | Â |
   Baseline to weeks 2 to 8 | -37.6 (3.66) | -23.4 (5.21) | 0.0291 |
   95% CI | -44.85, -30.35 | -33.74, -13.10 |  |
   Baseline to weeks 2 to 12 | -37.5 (3.76) | -25.5 (5.35) | 0.069 |
   95% CI | -44.98, -30.10 | -36.06, -14.88 |  |
Patients with ≥ 30% reduction, % |  |  |  |
   Baseline to weeks 2 to 8 | 49 | 40 | 0.090 |
   Baseline to weeks 2 to 12 | 50 | 44 | 0.277 |
Patients with ≥ 50% reduction, % |  |  |  |
   Baseline to weeks 2 to 8 | 35 | 30 | 0.270 |
   Baseline to weeks 2 to 12 | 40 | 28 | 0.065 |
PGIC | Â | Â | Â |
   Improved (very much, much) |  |  |  |
   Week 4, n | 84 | 40 |  |
N (%) | 31 (37) | 14 (35) | 1.0000 |
   Week 8, n | 78 | 35 |  |
N (%) | 34 (44) | 10 (29) | 0.1487 |
   Week 12, n | 81 | 41 |  |
N (%) | 32 (40) | 8 (20) | 0.0403 |