A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
NCT ID: NCT01736423
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2012-09-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Female Patients with D-IBS
YM060
oral
Interventions
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YM060
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patients satisfying the Rome III Diagnostic Criteria
2. Patients whose ≥25% of stools were loose or watery and \<25% of them were hard or lumpy stools
3. Patients who have abdominal pain or discomfort
4. 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 Criteria
1. Patients with a history of surgical resection of the stomach,gallbladder, small intestine or large intestine
2. Patients with a history or current evidence of inflammatory bowel disease
3. Patients with a history or current evidence of colitis ischemic
4. Patients with concurrent infectious enteritis
5. Patients with concurrent hyperthyroidism or hypothyroidism
6. Patients with concurrent active peptic ulcer
7. 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
20 Years
64 Years
FEMALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
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Hokkaido, , Japan
Kansai, , Japan
Kantou, , Japan
Kyushu, , Japan
Countries
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References
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Fukudo S, Kinoshita Y, Okumura T, Ida M, Hayashi K, Akiho H, Nakashima Y, Haruma K. Effect of ramosetron in female patients with irritable bowel syndrome with diarrhea: a phase III long-term study. J Gastroenterol. 2016 Sep;51(9):874-82. doi: 10.1007/s00535-016-1165-5. Epub 2016 Jan 22.
Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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060-CL-703
Identifier Type: -
Identifier Source: org_study_id
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