Back to resultsA Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
Primary Purpose
Diarrhea-predominant Irritable Bowel Syndrome
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
YM060
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea-predominant Irritable Bowel Syndrome focused on measuring YM060, Ramosetron, Diarrhea-predominant Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients satisfying the Rome III Diagnostic Criteria
- Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
- Patients who have abdominal pain or discomfort
- Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema
Exclusion Criteria:
- Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
- Patients with a history or current evidence of inflammatory bowel disease
- Patients with a history or current evidence of colitis ischemic
- Patients with concurrent infectious enteritis
- Patients with concurrent hyperthyroidism or hypothyroidism
- Patients with concurrent active peptic ulcer
- Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
YM060 group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
Monthly responder rate of stool form normalization at final point
Secondary Outcome Measures
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Change in weekly average scores of severity of abdominal pain/discomfort
Change in weekly average scores of stool form
Safety assessment of YM060
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01870895
Brief Title
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
Official Title
A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (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
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea-predominant Irritable Bowel Syndrome
Keywords
YM060, Ramosetron, Diarrhea-predominant Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
577 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YM060 group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
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
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
Time Frame
Up to 12 weeks
Title
Monthly responder rate of stool form normalization at final point
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Time Frame
Up to 12 weeks
Title
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Time Frame
Up to 12 weeks
Title
Change in weekly average scores of severity of abdominal pain/discomfort
Time Frame
Up to 12 weeks
Title
Change in weekly average scores of stool form
Time Frame
Up to 12 weeks
Title
Safety assessment of YM060
Time Frame
Up to 12 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 satisfying the Rome III Diagnostic Criteria
Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
Patients who have abdominal pain or discomfort
Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema
Exclusion Criteria:
Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
Patients with a history or current evidence of inflammatory bowel disease
Patients with a history or current evidence of colitis ischemic
Patients with concurrent infectious enteritis
Patients with concurrent hyperthyroidism or hypothyroidism
Patients with concurrent active peptic ulcer
Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyushu
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26551550
Citation
Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb;150(2):358-66.e8. doi: 10.1053/j.gastro.2015.10.047. Epub 2015 Nov 6.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=060-CL-702
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
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