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A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
YM060
placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Patients meeting the Rome III Diagnostic Criteria
  • Loose (mushy) or watery stools within the last 3 months
  • Abdominal discomfort and/or pain during their non-menstrual period

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 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo group

YM060 low-dose group

YM060 middle-dose group

YM060 high-dose group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in weekly average scores of stool form (appearance)
Safety assessed by the incidence of adverse events and abnormal values in lab-tests

Full Information

First Posted
January 5, 2011
Last Updated
October 9, 2015
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01274000
Brief Title
A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients
Official Title
Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to verify the superiority of YM060 (ramosetron) to placebo for female 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, Ramosetron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Title
YM060 low-dose group
Arm Type
Experimental
Arm Title
YM060 middle-dose group
Arm Type
Experimental
Arm Title
YM060 high-dose group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM060
Other Intervention Name(s)
ramosetron, Irribow
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Responder rate of patients reported global assessment of relief of IBS symptoms
Time Frame
for 4 weeks
Secondary Outcome Measure Information:
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
Change in weekly average scores of stool form (appearance)
Time Frame
Baseline and for 4 weeks
Title
Safety assessed by the incidence of adverse events and abnormal values in lab-tests
Time Frame
for 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients meeting the Rome III Diagnostic Criteria Loose (mushy) or watery stools within the last 3 months Abdominal discomfort and/or pain during their non-menstrual period 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
28205278
Citation
Fukudo S, Matsueda K, Haruma K, Ida M, Hayase H, Akiho H, Nakashima Y, Hongo M. Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13023. Epub 2017 Feb 16.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch.jsp
Description
Link to Results on JAPIC - enter 140635 in the JapicCTI-RNo. field (Japanese record)
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=060-CL-701
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

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