Diarrhea-predominant Irritable Bowel Syndrome
Conditions
Keywords
YM060, Ramosetron, Diarrhea-predominant Irritable Bowel Syndrome
Brief summary
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
Interventions
DRUGYM060
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients satisfying the Rome III Diagnostic Criteria 2. Patients whose ≥25% of stools were loose or watery and \<25% of them were hard or lumpy stools 3. Patients who have abdominal pain or discomfort 4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema
Exclusion criteria
1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine 2. Patients with a history or current evidence of inflammatory bowel disease 3. Patients with a history or current evidence of colitis ischemic 4. Patients with concurrent infectious enteritis 5. Patients with concurrent hyperthyroidism or hypothyroidism 6. Patients with concurrent active peptic ulcer 7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monthly responder rate of global assessment of relief of overall IBS symptoms at final point | Up to 12 weeks |
| Monthly responder rate of stool form normalization at final point | Up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in weekly average scores of severity of abdominal pain/discomfort | Up to 12 weeks |
| Monthly responder rate of global assessment of relief of abdominal pain/discomfort | Up to 12 weeks |
| Safety assessment of YM060 | Up to 12 weeks |
| Change in weekly average scores of stool form | Up to 12 weeks |
| Monthly responder rate of global assessment of improvement of abnormal bowel habits | Up to 12 weeks |
Countries
Japan
Outcome results
None listed