Back to resultsA Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
International
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, Nasea®, Irribow®, ramosetron
Eligibility Criteria
Inclusion Criteria: Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS Exclusion Criteria: Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00189813
First Posted
September 13, 2005
Last Updated
August 27, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.
1. Study Identification
Unique Protocol Identification Number
NCT00189813
Brief Title
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.
4. Oversight
5. Study Description
Brief Summary
This study will examine the efficacy, safety and tolerability of different 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, Nasea®, Irribow®, ramosetron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
691 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM060
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS
Exclusion Criteria:
Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Verbeeck
Organizational Affiliation
Director of Late Phase Development
Official's Role
Study Chair
Facility Information:
City
Plovdiv
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Ceske Budejovice
Country
Czech Republic
City
Hradec Kralove
Country
Czech Republic
City
Ostrava Hrabuvka
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Tabor
Country
Czech Republic
City
Usti nad Orlici
Country
Czech Republic
City
Tallinn
Country
Estonia
City
Tartu
Country
Estonia
City
Viljandi
Country
Estonia
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Dietzenbach
Country
Germany
City
Essen
Country
Germany
City
Frankfurt
Country
Germany
City
Friedberg
Country
Germany
City
Hamburg
Country
Germany
City
Hassloch
Country
Germany
City
Koenigstein
Country
Germany
City
Leipzig
Country
Germany
City
Mainz
Country
Germany
City
Marburg
Country
Germany
City
Potsdam
Country
Germany
City
Waltershausen
Country
Germany
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Bialystok
Country
Poland
City
Bydgoszcz
Country
Poland
City
Krakow
Country
Poland
City
Leszno
Country
Poland
City
Lublin
Country
Poland
City
Olawa
Country
Poland
City
Warszawa
Country
Poland
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Dnipropetrovsk
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lviv
Country
Ukraine
City
Odessa
Country
Ukraine
City
Simferopol
Country
Ukraine
City
Sumy
Country
Ukraine
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140542 in the JapicCTI-RNo. field
Learn more about this trial
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
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