Status:
COMPLETED
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Diarrhea-predominant Irritable Bowel Syndrome
Eligibility:
FEMALE
20-64 years
Phase:
PHASE3
Brief Summary
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-predom...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT01870895
Start Date
February 1 2013
End Date
February 1 2014
Last Update
October 12 2015
Active Locations (4)
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1
Hokkaido, Japan
2
Kansai, Japan
3
Kantou, Japan
4
Kyushu, Japan