Special Drug Use Surveillance of Irribow in Female Patients | NCT02612649

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Mar 31, 2018Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Nov 20, 2015

First Posted Date

Nov 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2024

Last Update Posted Date

Oct 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

793Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ramosetron group		Female patients with diarrhea-predominant irritable bowel syndrome	Drug: Ramosetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramosetron	Drug	Oral	Ramosetron group	YM060 Irribow

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidences of Adverse Drug Reactions		Up to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in frequency of bowel movements	Frequency of bowel movements is recorded daily	Baseline to Week 52
Change from baseline in form of stool	Classified based on Bristol Stool Form Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Female patients with diarrhea-predominant irritable bowel syndrome

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Director	Astellas Pharma Inc	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

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/.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Facility	Status	City	State	ZIP	Country	Contacts
		Numakunai	Iwate		Japan

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases