88 (P = .006) and 0.78 (P < .001), 0.88 (P = .011) and 0.80 (P < .001), and 0.89 (P = .022) and 0.82 (P < .001) at days 28, 56, and 84, respectively. Likewise, relative risk estimates for urgency episodes

for patients selleck chemical receiving 100 and 200 mg eluxadoline were 0.74 (P = .008) and 0.65 (P < .001), 0.76 (P = .013) and 0.67 (P < .001), and 0.77 (P = .024) and 0.69 (P = .002) at days 28, 56, and 84, respectively. No significant differences from placebo in incontinence episodes were observed. However, a trend for improvements in incontinence-free days was noted for patients who averaged at least 1 incontinent episode per day in the week before randomization (38.8 vs 26.5 incontinence-free days for 100-mg eluxadoline patients compared with placebo patients, respectively; P = .078). selleck chemicals Although changes over time in abdominal pain and stool consistency were only analyzed via the response definitions specified in the primary and secondary end points, reductions from baseline values followed a similar time course to those shown for the other bowel characteristics (data not shown). During the 2-week

follow-up period after week 12, values for abdominal pain, stool consistency, and bowel characteristics began to increase for all treatment groups, but remained below baseline levels. Consistent improvement during the course of the study was also seen in patients’ ratings of their global IBS symptoms, with peak effects again observed between the second and third months (Figure 3). For IBS Global Symptom scores, mean differences from placebo were statistically significant for patients

receiving 200 mg eluxadoline (−0.26; P < .001) at week 4 and for both the 100-mg (−0.19 and −0.26; P = .014 and 0.003, respectively) and 200-mg (−0.30 and −0.34; P < .001 and < .001, respectively) eluxadoline groups at weeks Low-density-lipoprotein receptor kinase 8 and 12. Likewise for IBS-SSS, mean differences from placebo were statistically significant for the 100-mg eluxadoline group at the end of weeks 4, 8, and 12 (−16.69, −33.55, and −50.40; P = .011; P < .001; and P < .001, respectively) and for the 200-mg eluxadoline group at the end of weeks 8 and 12 (−19.89 and −27.48; P = .012 and P = .011, respectively). Patients who received eluxadoline also reported significant improvement in their quality of life ( Figure 2). A greater improvement in IBS-QOL total scores was observed for patients receiving 100 mg and 200 mg eluxadoline compared with placebo at the end of weeks 4, 8, and 12. For patients receiving 100 mg eluxadoline, mean differences from placebo were 3.05 (P = .012), 5.82 (P < .001), and 8.60 (P < .001). For patients receiving 200 mg eluxadoline, mean differences were 3.31 (P = .007), 5.75 (P < .001), and 8.19 (P < .001) at the end of weeks 4, 8, and 12. Results from the EQ-5D questionnaire also revealed a statistically significant difference (P < .