Special Drug Use Surveillance of Irribow in Female Patients
- Registration Number
- NCT02612649
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 793
Inclusion Criteria
- Female patients with diarrhea-predominant irritable bowel syndrome
Exclusion Criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ramosetron group Ramosetron Female patients with diarrhea-predominant irritable bowel syndrome
- Primary Outcome Measures
Name Time Method Incidences of Adverse Drug Reactions Up to Week 52
- Secondary Outcome Measures
Name Time Method 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
Change from baseline in frequency of bowel movements Baseline to Week 52 Frequency of bowel movements is recorded daily
Change from baseline in melena Baseline to Week 52 Overall improvement Up to Week 52 Classified into the three scales (improved, no change or aggravated) or concluded as indeterminable.
Change from baseline in defecation urgency Baseline to Week 52 Change from baseline in abdominal pain or discomfort Baseline to Week 52 Abdominal pain or discomfort assessed based on numerical rating scale