Special Drug Use Surveillance of Irribow in Female Patients

Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial

Official title:

Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612649
• Other study ID #: IB0002
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: October 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

Drug:
• Ramosetron
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidences of Adverse Drug Reactions		Up to Week 52
Secondary	Change from baseline in frequency of bowel movements	Frequency of bowel movements is recorded daily	Baseline to Week 52
Secondary	Change from baseline in form of stool	Classified based on Bristol Stool Form Scale	Baseline to Week 52
Secondary	Change from baseline in sensation of incomplete bowel evacuation	Assessment based on numerical rating scale	Baseline to Week 52
Secondary	Change from baseline in defecation urgency		Baseline to Week 52
Secondary	Change from baseline in abdominal pain or discomfort	Abdominal pain or discomfort assessed based on numerical rating scale	Baseline to Week 52
Secondary	Change from baseline in melena		Baseline to Week 52
Secondary	Overall improvement	Classified into the three scales (improved, no change or aggravated) or concluded as indeterminable.	Up to Week 52