Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea

Background Global assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess “clinically meaningful improvements, focusing on the patient’s chief complaint and the severity of major IBS symptoms” in addition to global assessment to show how ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D).