Table 4.
Mean 24-hour average pain intensity score change from baseline—responder analysis, intent-to-treat population.
| Visit | API score reduction | No. (%) of patients | Fisher exact test (P) | |
|---|---|---|---|---|
| ISC 17536 (N = 70) | Placebo (N = 66) | |||
| Week 1 | ≥30% | 11 (15.71) | 2 (3.03) | 0.0173 |
| ≥50% | 0 | 0 | — | |
| Week 2 | ≥30% | 19 (27.14) | 17 (25.76) | 0.8466 |
| ≥50% | 5 (7.14) | 4 (6.06) | 1.0000 | |
| Week 3 | ≥30% | 29 (41.43) | 21 (31.82) | 0.2069 |
| ≥50% | 12 (17.14) | 7 (10.61) | 0.3209 | |
| Week 4 | ≥30% | 38 (54.29) | 30 (45.45) | 0.3911 |
| ≥50% | 21 (30.00) | 11 (16.67) | 0.0728 | |
| Week 6 | ≥30% | 38 (54.29) | 34 (51.52) | 0.8508 |
| ≥50% | 23 (32.86) | 19 (28.79) | 0.7016 | |
API, average pain intensity; BID, twice daily; ITT, intent-to-treat; N, number of patients.