A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
20 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients satisfying the Rome III Diagnostic Criteria
Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
Patients who have abdominal pain or discomfort
Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema
Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
Patients with a history or current evidence of inflammatory bowel disease
Patients with a history or current evidence of colitis ischemic
Patients with concurrent infectious enteritis
Patients with concurrent hyperthyroidism or hypothyroidism
Patients with concurrent active peptic ulcer
Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort