Special Drug Use Surveillance of Irribow in Female Patients
1 other identifier
observational
793
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedOctober 21, 2024
October 1, 2018
2.5 years
October 23, 2015
October 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidences of Adverse Drug Reactions
Up to Week 52
Secondary Outcomes (7)
Change from baseline in frequency of bowel movements
Baseline to Week 52
Change from baseline in form of stool
Baseline to Week 52
Change from baseline in sensation of incomplete bowel evacuation
Baseline to Week 52
Change from baseline in defecation urgency
Baseline to Week 52
Change from baseline in abdominal pain or discomfort
Baseline to Week 52
- +2 more secondary outcomes
Study Arms (1)
Ramosetron group
Female patients with diarrhea-predominant irritable bowel syndrome
Interventions
Eligibility Criteria
Female patients with diarrhea-predominant irritable bowel syndrome
You may qualify if:
- Female patients with diarrhea-predominant irritable bowel syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Numakunai, Iwate, Japan
Unknown Facility
Aichi, Japan
Unknown Facility
Akita, Japan
Unknown Facility
Chiba, Japan
Unknown Facility
Fukui, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Fukushima, Japan
Unknown Facility
Gifu, Japan
Unknown Facility
Gunma, Japan
Unknown Facility
Hiroshima, Japan
Unknown Facility
Hyōgo, Japan
Unknown Facility
Ibaraki, Japan
Unknown Facility
Kagoshima, Japan
Unknown Facility
Kanagawa, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Mie, Japan
Unknown Facility
Miyagi, Japan
Unknown Facility
Miyazaki, Japan
Unknown Facility
Nagano, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Okinawa, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Ōita, Japan
Unknown Facility
Saitama, Japan
Unknown Facility
Shiga, Japan
Unknown Facility
Shizuoka, Japan
Unknown Facility
Tochigi, Japan
Unknown Facility
Tokyo, Japan
Unknown Facility
Tottori, Japan
Unknown Facility
Toyama, Japan
Unknown Facility
Yamagata, Japan
Unknown Facility
Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2015
First Posted
November 24, 2015
Study Start
October 1, 2015
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
October 21, 2024
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.