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

TABLE 4 .

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).