Parameter | Statistic | PBO (n = 37) | OXY IR 30 mg (n = 37) | OXY IR 60 mg (n = 37) | ELX 100 mg (n = 35) | ELX 300 mg (n = 36) | ELX 1000 mg (n = 35) |
---|---|---|---|---|---|---|---|
Overall Drug Liking VAS | |||||||
At 12 h | Mean (S.D.) | 51.4 (13.6) | 77.3 (17.5) | 77.9 (19.2) | 50.5 (19.7) | 47.2 (24.9) | 49.8 (24.0) |
Median | 50.0 | 81.0 | 78.0 | 50.0 | 50.0 | 50.0 | |
P valuea | — | *** | *** | ††† ‡‡‡ | ††† ‡‡‡ | ††† ‡‡‡ | |
Take Drug Again VAS | |||||||
At 12 h | Mean (S.D.) | 15.1 (30.9) | 79.4 (25.7) | 74.3 (30.5) | 18.0 (33.6) | 22.5 (30.7) | 26.7 (34.1) |
Median | 0.0 | 86.0 | 90.0 | 0.0 | 0.5 | 2.0 | |
P valuea | — | *** | *** | ††† ‡‡‡ | * ††† ‡‡‡ | ††† ‡‡‡ | |
Bad Effects VAS | |||||||
Emax | Mean (S.D.) | 8.8 (21.3) | 23.4 (29.8) | 40.5 (37.9) | 13.3 (29.3) | 26.9 (28.3) | 23.1 (30.5) |
Median | 0.0 | 3.0 | 28.0 | 0.0 | 14.5 | 11.0 | |
P valuea | — | ** | *** | NS | ** | * | |
Pupil diameter | |||||||
MPC | Mean (S.D.) | 0.8 (0.7) | 2.2 (0.7) | 2.6 (0.8) | 0.7 (0.5) | 0.9 (0.5) | 0.9 (0.5) |
Median | 0.7 | 2.0 | 2.5 | 0.8 | 0.8 | 0.9 | |
P valuea | — | *** | *** | ††† ‡‡‡ | ††† ‡‡‡ | ††† ‡‡‡ |
ELX, eluxadoline; MPC, maximum pupil constriction; NS, not significant; OXY IR, oxycodone immediate release; PBO, placebo.
↵a P values are for pairwise comparisons of median differences between treatments, assessed using the Wilcoxon signed-rank test.
↵* Significant versus PBO (P < 0.05); **significant versus PBO (P < 0.01);
↵*** significant versus PBO (P < 0.0001); †††significant versus OXY IR 30 mg (P < 0.0001);
‡‡ significant versus OXY IR 60 mg (P < 0.01); ‡‡‡significant versus OXY IR 60 mg (P < 0.0001).