Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo group | Placebo Comparator |
| |
| YM060 low-dose group | Experimental |
| |
| YM060 middle-dose group | Experimental |
| |
| YM060 high-dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM060 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate of patients reported global assessment of relief of IBS symptoms | for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain | for 4 weeks | |
| Responder rate of patients reported assessment of improvement of abnormal bowel habits | for 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 28205278 | Derived | Fukudo S, Matsueda K, Haruma K, Ida M, Hayase H, Akiho H, Nakashima Y, Hongo M. Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13023. Epub 2017 Feb 16. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C071315 | ramosetron |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | oral |
|
| Change in weekly average scores of stool form (appearance) | Baseline and for 4 weeks |
| Safety assessed by the incidence of adverse events and abnormal values in lab-tests | for 4 weeks |
| Kansai |
| Japan |
| Kantou | Japan |
| Kyusyu | Japan |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |