NPRS Scores | NGX-4010 (n = 102) | Control (n = 53) | P-value |
---|---|---|---|
Baseline, LS mean (SE) | 5.4 (0.16) | 5.3 (0.22) | Â |
   95% CI | 5.12, 5.73 | 4.87, 5.72 |  |
Change, mean (SE) | Â | Â | Â |
   Baseline to weeks 2 to 8 | -1.8 (0.20) | -1.6 (0.27) | 0.462 |
   95% CI | -2.23, -1.45 | -2.13, -1.05 |  |
   Baseline to weeks 2 to 12 | -1.8 (0.20) | -1.7 (0.28) | 0.750 |
   95% CI | -2.25, -1.45 | -2.29, -1.18 |  |
Percent Change, mean (SE) | Â | Â | Â |
   Baseline to weeks 2 to 8 | -36.5 (3.68) | -29.9 (5.10) | 0.296 |
   95% CI | -43.72, -29.19 | -39.94, -19.78 |  |
   Baseline to weeks 2 to 12 | -36.6 (3.75) | -32.3 (5.21) | 0.509 |
   95% CI | -44.02, -29.19 | -42.63, -22.05 |  |
Patients with ≥ 30% reduction, % |  |  |  |
   Baseline to weeks 2 to 8 | 49 | 45 | 0.574 |
   Baseline to weeks 2 to 12 | 49 | 49 | 0.956 |
Patients with ≥ 50% reduction, % |  |  |  |
   Baseline to weeks 2 to 8 | 36 | 36 | 0.930 |
   Baseline to weeks 2 to 12 | 39 | 36 | 0.628 |
PGIC | Â | Â | Â |
   Improved (very much, much) |  |  |  |
   Week 4, n | 100 | 49 |  |
N (%) | 40 (40) | 19 (39) | 1.0000 |
   Week 8, n | 91 | 43 |  |
N (%) | 43 (47) | 14 (33) | 0.1351 |
   Week 12, n | 95 | 50 |  |
N (%) | 41 (43) | 15 (30) | 0.1518 |