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Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00189696
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: YM060 Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea





Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189696


Locations
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Japan
Chubu region, Japan
Kanto region, Japan
Shikoku region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Study Director, Clinical Development III Astellas Pharma Inc
Additional Information:
Publications:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00189696    
Other Study ID Numbers: 060-CL-202
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by Astellas Pharma Inc:
Irritable Bowel Syndrome, Diarrhea
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases