Table 2.
Efficacy Analysis of ONO‐4474
| Week 6 (2 Weeks After | ||||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Week 2 | Week 4 | Treatment) | |||||
| ONO‐4474 | Placebo | ONO‐4474 | Placebo | ONO‐4474 | Placebo | ONO‐4474 | Placebo | |
| VAS24, mm | ||||||||
| N | 55 | 55 | 52 | 49 | 49 | 50 | 48 | 48 |
| Mean (SD) | 72.8 (9.1) | 71.2 (8.5) | 56.9 (21.1) | 56.7 (18.6) | 45.7 (23.6) | 51.8 (21.1) | 56.4 (20.5) | 55.9 (19.0) |
| Mean change from baseline (SD) | – | – | −16.1 (21.0) | −14.8 (16.7) | −26.9 (25.0) | −19.5 (19.6) | −16.4 (19.0) | −14.8 (16.9) |
| WOMAC, mm | ||||||||
| N | 55 | 54 | 51 | 52 | 50 | 52 | 50 | 49 |
| Mean (SD) | 60.3 (14.0) | 59.3 (13.5) | 48.5 (23.1) | 44.6 (18.7) | 38.1 (24.0) | 42.8 (18.7) | 47.1 (22.3) | 44.8 (19.3) |
| Mean change from baseline (SD) | – | – | −11.7 (16.7) | −14.3 (16.0)a | −21.3 (19.2) | −16.8 (16.0)a | −12.7 (16.8) | −14.2 (16.5)b |
| WOMAC (pain), mm | ||||||||
| N | 55 | 54 | 51 | 52 | 50 | 52 | 50 | 49 |
| Mean (SD) | 62.3 (12.4) | 61.0 (13.1) | 48.7 (22.3) | 45.0 (18.2) | 38.1 (23.4) | 42.6 (18.7) | 46.5 (22.0) | 45.4 (18.1) |
| Mean change from baseline (SD) | – | – | −13.6 (17.1) | −15.1 (18.3)a | −23.5 (21.1) | −18.0 (18.5)a | −15.0 (18.3) | −14.6 (18.3)b |
| PGA, mm | ||||||||
| N | 55 | 55 | 53 | 52 | 50 | 52 | 51 | 50 |
| Mean (SD) | 68.9 (11.7) | 65.7 (11.1) | 52.4 (25.8) | 50.7 (20.3) | 38.8 (25.3) | 44.9 (21.4) | 53.7 (22.0) | 49.0 (21.6) |
| Mean change from baseline (SD) | – | – | −17.2 (24.6) | −14.2 (20.0) | −29.6 (25.5) | −20.6 (21.7) | −14.9 (19.4) | −16.4 (22.8) |
PGA, Patient Global Assessment; SD, standard deviation; VAS24, visual analog scale over 24 hours; WOMAC, Western Ontario and McMaster Universities OA Index.
a
n = 51.
b
n = 48.