To evaluate the efficacy and safety of YM060 once daily for female patients with
diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52
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Full eligibility criteria for NCT01736423
Ages eligible for Study
20 Years to 64 Years
Genders eligible for Study
Accepts Healthy Volunteers
Female patients who meet the following criteria:
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 who meet any of the following criteria:
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
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View full eligibility
Tris trial is registered with FDA with number: NCT01736423. The sponsor of the trial is Astellas Pharma Inc and it is looking for 151 volunteers for the current phase.
Official trial title: A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
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