A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
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ClinicalTrials.gov Identifier: NCT00918411 |
Recruitment Status :
Completed
First Posted : June 11, 2009
Last Update Posted : October 12, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Irritable Bowel Syndrome | Drug: Ramosetron Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Official Title: | Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: Ramosetron group
oral
|
Drug: Ramosetron
oral
Other Names:
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Placebo Comparator: Placebo group
oral
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Drug: Placebo
oral |
- IBS severity index (Japanese version) [ Time Frame: 12 weeks ]
- Patient reported global assessment of relief of IBS symptoms [ Time Frame: 12 weeks ]
- Patient reported assessment of relief of abdominal discomfort and/or pain [ Time Frame: 12 weeks ]
- Patient reported assessment of improvement of abdominal bowel habits [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 20 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients meeting the Rome III Diagnostic Criteria
- Loose (mushy) or watery stools within the last 3 months
Exclusion Criteria:
- Patients having hyperthyroidism or hypothyroidism

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918411
Japan | |
Hokkaido, Japan | |
Kansai, Japan | |
Kantou, Japan | |
Kyusyu, Japan |
Study Chair: | Use Central Contact | Astellas Pharma Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00918411 |
Other Study ID Numbers: |
060-CL-500 |
First Posted: | June 11, 2009 Key Record Dates |
Last Update Posted: | October 12, 2015 |
Last Verified: | October 2015 |
diarrhea IBS Colonic diseases YM060 |
Irritable Bowel Syndrome Syndrome Diarrhea Disease Pathologic Processes Signs and Symptoms, Digestive Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Ramosetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |