Status:
COMPLETED
A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Irritable Bowel Syndrome
Eligibility:
MALE
20-64 years
Phase:
PHASE4
Brief Summary
A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.
Eligibility Criteria
Inclusion
- Patients meeting the Rome III Diagnostic Criteria
- Loose (mushy) or watery stools within the last 3 months
Exclusion
- Patients with a history of surgical resection of the stomach, small intestine or large intestine
- Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
- Patients with a history or current diagnosis of colitis ischemic
- Patients with a current diagnosis of enteritis infectious
- Patients with a current diagnosis of hyperthyroidism or hypothyroidism
- Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
- Patients with a history or current diagnosis of malignant tumor
- Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT01225237
Start Date
October 1 2010
End Date
August 1 2011
Last Update
October 15 2014
Active Locations (4)
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1
Hokkaido, Japan
2
Kansai, Japan
3
Kantou, Japan
4
Kyusyu, Japan