Back to resultsPhase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
YM060
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Diarrhea
Eligibility Criteria
Inclusion Criteria: Patients satisfying the Rome II Diagnostic Criteria. Patients in whom no organic changes were observed in large intestine. Exclusion Criteria: Patients have diseases which interfere with evaluation of the efficacy and safety in this study. Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00189696
First Posted
September 12, 2005
Last Updated
October 9, 2015
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00189696
Brief Title
Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
Brief Summary
This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM060
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients satisfying the Rome II Diagnostic Criteria.
Patients in whom no organic changes were observed in large intestine.
Exclusion Criteria:
Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director, Clinical Development III
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu region
Country
Japan
City
Kanto region
Country
Japan
City
Shikoku region
Country
Japan
City
Tohoku Region
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
18618371
Citation
Matsueda K, Harasawa S, Hongo M, Hiwatashi N, Sasaki D. A randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndrome. Scand J Gastroenterol. 2008;43(10):1202-11. doi: 10.1080/00365520802240255.
Results Reference
background
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=060-CL-202
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
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