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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YM060 group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM060 | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Monthly responder rate of global assessment of relief of overall IBS symptoms at final point | Up to 12 weeks | |
| Monthly responder rate of stool form normalization at final point | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Monthly responder rate of global assessment of relief of abdominal pain/discomfort | Up to 12 weeks | |
| Monthly responder rate of global assessment of improvement of abnormal bowel habits | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26551550 | Derived | Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb;150(2):358-66.e8. doi: 10.1053/j.gastro.2015.10.047. Epub 2015 Nov 6. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
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| Placebo | Drug | oral |
|
| Change in weekly average scores of severity of abdominal pain/discomfort | Up to 12 weeks |
| Change in weekly average scores of stool form | Up to 12 weeks |
| Safety assessment of YM060 | Up to 12 weeks |
| Kansai |
| Japan |
| Kantou | Japan |
| Kyushu | Japan |