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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 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female Patients with D-IBS | Experimental |
|
| 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 | up to 52 weeks | |
| Monthly responder rate of stool form normalization | up to 52 weeks | |
| Monthly responder rate of global assessment of relief of abdominal pain/discomfort | up to 52 weeks | |
| Monthly responder rate of global assessment of improvement of abnormal bowel habits | up to 52 weeks | |
| Change in weekly average of scores of severity of abdominal pain/discomfort | up to 52 weeks | |
| Change in weekly average of scores of stool form | up to 52 weeks | |
| Change in weekly average of stool frequency | up to 52 weeks | |
| Rate of days without urgency | up to 52 weeks | |
| Rate of days without feeling of incomplete bowel movement | up to 52 weeks | |
| Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales | 4, 8, 12, 28 and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed through AEs and clinical laboratory values | up to 52 weeks |
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Inclusion Criteria:
Female patients who meet the following criteria:
Exclusion Criteria:
Patients who meet any of the following 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 |
|---|---|---|---|
| 26800997 | Derived | 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. |
| 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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| Kansai |
| Japan |
| Kantou | Japan |
| Kyushu | Japan |