A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ramosetron

Criteria

Inclusion Criteria:

• Patients meeting the Rome III Diagnostic Criteria

• Loose (mushy) or watery stools within the last 3 months

• Abdominal discomfort and/or pain during their non-menstrual period

Exclusion Criteria:

• 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