Table 2.
Results of the confirmatory analysis of the endpoints
| Endpoint | Placebo (n = 56) | Verum (n = 54) | p value |
|---|---|---|---|
| Discomfort sum score at day 10 Mean (SD), median, range | 4.7 (7.8), 5.0, -13 to 24 | 7.3 (8.1), 7.0, –18 to 23 | 0.024 |
| Efficacy assessment by the investigator at the end of the study n (%) | |||
| Complete healing at day 10 | 26 (46) | 36 (67) | 0.037* |
| Number of open abscesses (day 10) | 40 (71) | 36 (67) | 0.036* |
| Complete healing | 19 (48) | 26 (72) | |
| Therapy | |||
| Successful | 27 (48) | 38 (70) | 0.021 * |
| Partially successful | 12 (21) | 7 (13) | |
| Not successful | 17 (30) | 9 (17) | |
| Mean abscess size [mean (SD)], cm | |||
| Baseline | 2.2 (0.8) | 2.3 (1.0) | 0.9 |
| Day 10 | 0.7 (0.8) | 0.5 (0.9) | 0.07 |
Fisher's exact test.