Diarrhea-predominant Irritable Bowel Syndrome
Conditions
Keywords
YM060, Ramosetron, long term study, Diarrhea-predominant Irritable Bowel Syndrome, Female
Brief summary
To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).
Interventions
DRUGYM060
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Female patients who meet the following 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
Patients who meet any of the following 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 |
|---|---|
| Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales | 4, 8, 12, 28 and 52 weeks |
| Monthly responder rate of global assessment of relief of overall IBS symptoms | up to 52 weeks |
| Monthly responder rate of stool form normalization | up to 52 weeks |
| Monthly responder rate of global assessment of relief of abdominal pain/discomfort | up to 52 weeks |
| Monthly responder rate of global assessment of improvement of abnormal bowel habits | up to 52 weeks |
| Change in weekly average of scores of severity of abdominal pain/discomfort | up to 52 weeks |
| Change in weekly average of scores of stool form | up to 52 weeks |
| Change in weekly average of stool frequency | up to 52 weeks |
| Rate of days without urgency | up to 52 weeks |
| Rate of days without feeling of incomplete bowel movement | up to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed through AEs and clinical laboratory values | up to 52 weeks |
Countries
Japan
Outcome results
None listed