Back to resultsA Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Primary Purpose
Diarrhea-predominant 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 Diarrhea-predominant Irritable Bowel Syndrome focused on measuring YM060, Ramosetron, long term study, Diarrhea-predominant Irritable Bowel Syndrome, Female
Eligibility Criteria
Inclusion Criteria:
Female patients who meet the following 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 who meet any of the following 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 Type
Experimental
Arm Label
Female Patients with D-IBS
Arm Description
Outcomes
Primary Outcome Measures
Monthly responder rate of global assessment of relief of overall IBS symptoms
Monthly responder rate of stool form normalization
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 of scores of severity of abdominal pain/discomfort
Change in weekly average of scores of stool form
Change in weekly average of stool frequency
Rate of days without urgency
Rate of days without feeling of incomplete bowel movement
Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales
Secondary Outcome Measures
Safety assessed through AEs and clinical laboratory values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01736423
Brief Title
A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Official Title
A Long Term Study of YM060 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
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 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 evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).
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, long term study, Diarrhea-predominant Irritable Bowel Syndrome, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Female Patients with D-IBS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM060
Other Intervention Name(s)
Ramosetron
Intervention Description
oral
Primary Outcome Measure Information:
Title
Monthly responder rate of global assessment of relief of overall IBS symptoms
Time Frame
up to 52 weeks
Title
Monthly responder rate of stool form normalization
Time Frame
up to 52 weeks
Title
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Time Frame
up to 52 weeks
Title
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Time Frame
up to 52 weeks
Title
Change in weekly average of scores of severity of abdominal pain/discomfort
Time Frame
up to 52 weeks
Title
Change in weekly average of scores of stool form
Time Frame
up to 52 weeks
Title
Change in weekly average of stool frequency
Time Frame
up to 52 weeks
Title
Rate of days without urgency
Time Frame
up to 52 weeks
Title
Rate of days without feeling of incomplete bowel movement
Time Frame
up to 52 weeks
Title
Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales
Time Frame
4, 8, 12, 28 and 52 weeks
Secondary Outcome Measure Information:
Title
Safety assessed through AEs and clinical laboratory values
Time Frame
up to 52 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:
Female patients who meet the following 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 who meet any of the following 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
26800997
Citation
Fukudo S, Kinoshita Y, Okumura T, Ida M, Hayashi K, Akiho H, Nakashima Y, Haruma K. Effect of ramosetron in female patients with irritable bowel syndrome with diarrhea: a phase III long-term study. J Gastroenterol. 2016 Sep;51(9):874-82. doi: 10.1007/s00535-016-1165-5. Epub 2016 Jan 22.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=060-CL-703
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
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