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A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Ramosetron

Placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring diarrhea, IBS, Colonic disease, YM060

Eligibility Criteria

20 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients meeting the Rome III Diagnostic Criteria
Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

Patients with a history of surgical resection of the stomach, small intestine or large intestine
Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
Patients with a history or current diagnosis of colitis ischemic
Patients with a current diagnosis of enteritis infectious
Patients with a current diagnosis of hyperthyroidism or hypothyroidism
Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
Patients with a history or current diagnosis of malignant tumor
Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ramosetron group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Responder rate of stool form normalization

Secondary Outcome Measures

Responder rate of patients reported global assessment of relief of IBS symptoms

Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain

Responder rate of patients reported assessment of improvement of abnormal bowel habits

Safety assessed by the incidence of adverse events and abnormal values in labo-tests

Full Information

NCT ID

NCT01225237

First Posted

October 19, 2010

Last Updated

October 14, 2014

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01225237

Brief Title

A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

Official Title

Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - Double-blind, Parallel-group Comparative Study in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

diarrhea, IBS, Colonic disease, YM060

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

296 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ramosetron group

Arm Type

Experimental

Arm Title

Placebo group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ramosetron

Other Intervention Name(s)

Irribow, YM060

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral

Primary Outcome Measure Information:

Title

Responder rate of stool form normalization

Time Frame

For 4 weeks

Secondary Outcome Measure Information:

Title

Responder rate of patients reported global assessment of relief of IBS symptoms

Time Frame

For 4 weeks

Title

Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain

Time Frame

For 4 weeks

Title

Responder rate of patients reported assessment of improvement of abnormal bowel habits

Time Frame

For 4 weeks

Title

Safety assessed by the incidence of adverse events and abnormal values in labo-tests

Time Frame

For 4 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients meeting the Rome III Diagnostic Criteria Loose (mushy) or watery stools within the last 3 months Exclusion Criteria: Patients with a history of surgical resection of the stomach, small intestine or large intestine Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative) Patients with a history or current diagnosis of colitis ischemic Patients with a current diagnosis of enteritis infectious Patients with a current diagnosis of hyperthyroidism or hypothyroidism Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study Patients with a history or current diagnosis of malignant tumor Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Use Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kantou

Country

Japan

City

Kyusyu

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24315882

Citation

Fukudo S, Ida M, Akiho H, Nakashima Y, Matsueda K. Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea. Clin Gastroenterol Hepatol. 2014 Jun;12(6):953-9.e4. doi: 10.1016/j.cgh.2013.11.024. Epub 2013 Dec 4.

Results Reference

background

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch.jsp

Description

Link to Results on JAPIC - enter 140634 in the JapicCTI-RNo. field (Japanese record)

Learn more about this trial

A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

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