849 Fecal Immunochemical Test Has Lower Performance in Detecting Early and Proximal Advanced Colorectal Neoplasm

responders. Secondary endpoints included changes from baseline in weekly, monthly, and overall SBM frequency; time-to-first SBM; and overall mean changes from baseline in OBDrelated symptoms. Results: Significantly more patients in the lubiprostone group than in the placebo group were overall SBM responders during the 12-week treatment (26.9% vs. 18.6%, p=0.035). Overall, weekly and monthly changes from baseline in SBM frequencies demonstrated lubiprostone superiority over placebo overall, and at every treatment week and month, with statistical significance achieved overall (p=0.005), at 8 of the 12 treatment weeks (p≤0.039), as well as at each treatment month (p≤0.041). In addition, median time to first SBM was significantly shorter for lubiprostone-treated patients vs placebo (24.3 vs 38.5 hours, p=0.019), with a significantly higher proportion of lubiprostone patients reporting their first SBM within 4, 8, 12, 24, and 48 hours of first dose (p≤0.022). Straining, stool consistency, and constipation severity were also statistically significantly improved for lubiprostone vs placebo (p=0.002, p<0.001, and p=0.007, respectively). The most common treatment-related adverse events (AEs) reported by lubiprostone-treated patients were diarrhea (9.6%), nausea (8.2%), and abdominal pain (5.5%). There were no drug-related serious AEs reported for patients taking lubiprostone. Conclusion: Lubiprostone significantly improved SBM response and OBD symptoms in this 12-week, placebo-controlled study. Furthermore, lubiprostone was well tolerated in this patient population.