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. 2016 Dec;359(3):471–481. doi: 10.1124/jpet.116.236547

TABLE 3 .

Effects on secondary measures following oral drug administration (PD analysis set)

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).