Overview

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