- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189813
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
August 27, 2014 updated by: Astellas Pharma Inc
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
This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.
Study Overview
Study Type
Interventional
Enrollment (Actual)
691
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Ceske Budejovice, Czech Republic
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Hradec Kralove, Czech Republic
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Ostrava Hrabuvka, Czech Republic
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Praha, Czech Republic
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Tabor, Czech Republic
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Usti nad Orlici, Czech Republic
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Tallinn, Estonia
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Tartu, Estonia
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Viljandi, Estonia
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Berlin, Germany
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Bochum, Germany
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Dietzenbach, Germany
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Essen, Germany
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Frankfurt, Germany
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Friedberg, Germany
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Hamburg, Germany
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Hassloch, Germany
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Koenigstein, Germany
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Leipzig, Germany
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Mainz, Germany
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Marburg, Germany
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Potsdam, Germany
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Waltershausen, Germany
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Vilnius, Lithuania
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Bialystok, Poland
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Bydgoszcz, Poland
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Krakow, Poland
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Leszno, Poland
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Lublin, Poland
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Olawa, Poland
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Warszawa, Poland
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Moscow, Russian Federation
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St. Petersburg, Russian Federation
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Yaroslavl, Russian Federation
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Dnipropetrovsk, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Odessa, Ukraine
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Simferopol, Ukraine
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Sumy, Ukraine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: F. Verbeeck, Director of Late Phase Development
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 27, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060-CL-305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
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University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
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University of ViennaCompleted
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Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
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Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
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Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on YM060
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Astellas Pharma IncCompletedIrritable Bowel SyndromeJapan
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Astellas Pharma IncCompletedDiarrhea-predominant Irritable Bowel SyndromeJapan
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Astellas Pharma IncCompletedHealthy | Plasma Concentration of YM060Japan
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Astellas Pharma IncCompletedDiarrhea-predominant Irritable Bowel SyndromeJapan
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Astellas Pharma IncCompletedDiarrhea-predominant Irritable Bowel SyndromeJapan
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Astellas Pharma IncCompletedHealthy | Plasma Concentration of YM060Japan
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Astellas Pharma IncCompletedIrritable Bowel SyndromeJapan
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Astellas Pharma IncCompletedIrritable Bowel SyndromeJapan
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Astellas Pharma IncCompletedIrritable Bowel SyndromeJapan