- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189696
Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
October 9, 2015 updated by: Astellas Pharma Inc
This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.
Study Overview
Study Type
Interventional
Phase
- Phase 3
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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Chubu region, Japan
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Kanto region, Japan
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Shikoku region, Japan
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Tohoku Region, Japan
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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
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
Investigators
- Study Chair: Study Director, Clinical Development III, Astellas Pharma Inc
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 Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
October 12, 2015
Last Update Submitted That Met QC Criteria
October 9, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060-CL-202
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 IncAstellas Pharma Europe B.V.CompletedIrritable Bowel SyndromePoland, Germany, Bulgaria, Ukraine, Estonia, Russian Federation, Czech Republic, Lithuania
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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 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