Diarrhea-predominant Irritable Bowel Syndrome
Conditions
Keywords
Irritable bowel syndrome, YM060, Ramosetron, Survey
Brief summary
The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.
Interventions
DRUGRamosetron
Oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Female patients with diarrhea-predominant irritable bowel syndrome
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of Adverse Drug Reactions | Up to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in frequency of bowel movements | Baseline to Week 52 | Frequency of bowel movements is recorded daily |
| Change from baseline in form of stool | Baseline to Week 52 | Classified based on Bristol Stool Form Scale |
| Change from baseline in sensation of incomplete bowel evacuation | Baseline to Week 52 | Assessment based on numerical rating scale |
| Overall improvement | Up to Week 52 | Classified into the three scales (improved, no change or aggravated) or concluded as indeterminable. |
| Change from baseline in abdominal pain or discomfort | Baseline to Week 52 | Abdominal pain or discomfort assessed based on numerical rating scale |
| Change from baseline in melena | Baseline to Week 52 | — |
| Change from baseline in defecation urgency | Baseline to Week 52 | — |
Countries
Japan
Outcome results
None listed