A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
NCT ID: NCT00918411
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
PHASE4
98 participants
INTERVENTIONAL
2009-06-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Ramosetron group
oral
Ramosetron
oral
Placebo group
oral
Placebo
oral
Interventions
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Ramosetron
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Loose (mushy) or watery stools within the last 3 months
Exclusion Criteria
20 Years
64 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Hokkaido, , Japan
Kansai, , Japan
Kantou, , Japan
Kyusyu, , Japan
Countries
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References
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Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. 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. Biopsychosoc Med. 2017 Mar 16;11:8. doi: 10.1186/s13030-017-0093-9. eCollection 2017.
Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 11;11:7. doi: 10.1186/s13030-017-0092-x. eCollection 2017.
Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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060-CL-500
Identifier Type: -
Identifier Source: org_study_id
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