- The proportion of patients with a first spontaneous bowel movement (SBM), at 4, 8, 12, 24 and 48 hours post-dose was found to be statistically significant over placebo (p=0.002, p=0.017, p=0.021, p=0.016 and p=0.022, respectively) with the median time to first SBM being 24.25 hours for those on lubiprostone versus 38.5 hours on placebo (p=0.019).
- Greater proportions of lubiprostone subjects experienced improvement in their OBD symptoms over the 12 week period than did placebo subjects, including: straining associated with SBMs (p=0.002), stool consistency of SBMs (p<0.001), constipation severity (p=0.007), abdominal bloating (p=0.208, not statistically significant) and abdominal discomfort (p=0.048).
- Weekly changes from baseline in SBM frequency (lubiprostone vs. placebo) were significantly different at 8 of the 12 treatment weeks for lubiprostone vs. placebo, with overall statistical significance achieved (p=0.005).
Sucampo Presents Detailed Results Of Positive Phase 3 Trial Of Lubiprostone In Opioid-Induced Bowel Dysfunction (OBD)
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