Effects on secondary measures following intranasal drug administration (PD analysis set)
Pairwise comparisons were assessed using the Wilcoxon signed-rank test.
| Parameter | Statistic | PBO lactose (n = 32) | PBO ELX (n = 34) | OXY IR 15 mg (n = 32) | OXY IR 30 mg (n = 32) | ELX 100 mg (n = 32) | ELX 200 mg (n = 32) |
|---|---|---|---|---|---|---|---|
| Overall Drug Liking VAS | |||||||
| At 12 h | Mean (S.D.) | 43.8 (16.8) | 37.6 (22.9) | 76.4 (25.3) | 80.9 (22.8) | 20.7 (26.9) | 17.0 (26.7) |
| Median | 50.0 | 50.0 | 76.0 | 88.0 | 6.5 | 0.0 | |
| P valuea | — | NS | *** | *** | *** §§ ††† ‡‡‡ | *** §§§ ††† ‡‡‡ | |
| Take Drug Again VAS | |||||||
| At 12 h | Mean (S.D.) | 6.6 (17.7) | 7.0 (19.0) | 78.4 (30.5) | 81.4 (22.5) | 15.3 (27.5) | 9.4 (22.5) |
| Median | 0.0 | 0.0 | 94.0 | 94.0 | 0.0 | 0.0 | |
| P valueb | — | NS | *** | *** | ††† ‡‡‡ | ††† ‡‡‡ | |
| Bad Effects VAS | |||||||
| Emax | Mean (S.D.) | 2.2 (8.8) | 17.4 (25.0) | 22.6 (28.2) | 35.2 (35.0) | 62.8 (38.7) | 74.2 (32.0) |
| Median | 0.0 | 0.0 | 11.5 | 26.0 | 74.5 | 83.5 | |
| P valueb | — | * | * | *** | *** §§§ ††† ‡‡ | *** §§§ ††† ‡‡‡ | |
| Pupil diameter | |||||||
| MPC | Mean (S.D.) | 0.6 (0.5) | 0.5 (0.5) | 2.2 (0.8) | 2.7 (0.8) | 1.1 (0.6) | 1.1 (0.6) |
| Median | 0.6 | 0.5 | 2.2 | 2.7 | 1.0 | 1.1 | |
| P valuea | — | — | *** | *** | *** §§§ ††† ‡‡‡ | *** §§§ ††† ‡‡‡ |
ELX, eluxadoline; LS, least squares; MPC, maximum pupil constriction; NS, not significant; OXY IR, oxycodone immediate release; PBO, placebo.
↵a P values are for pairwise comparisons of LS mean differences between treatments.
↵b P values are for pairwise comparisons of median differences between treatments. Both assessed using the Wilcoxon signed-rank test.
↵* Significant versus PBO lactose (P < 0.05);***significant versus PBO lactose (P < 0.0001);§§significant versus PBO ELX (P < 0.01); §§§significant versus PBO ELX (P < 0.0001); †††significant versus OXY IR 15 mg (P < 0.0001); ‡‡significant versus OXY IR 30 mg (P < 0.01); ‡‡‡significant versus OXY IR 30 mg (P < 0.0001).