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The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramosetron group | Experimental | oral |
|
| Placebo group | Placebo Comparator | oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramosetron | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| IBS severity index (Japanese version) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported global assessment of relief of IBS symptoms | 12 weeks | |
| Patient reported assessment of relief of abdominal discomfort and/or pain | 12 weeks | |
| Patient reported assessment of improvement of abdominal bowel habits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28331539 | Derived | 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. | |
| 28293280 | Derived |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
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| Placebo | Drug | oral |
|
| 12 weeks |
| Kansai |
| Japan |
| Kantou | Japan |
| Kyusyu | Japan |
| 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. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |