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

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ClinicalTrials.gov Identifier: NCT00189696

Recruitment Status : Completed

First Posted : September 19, 2005

Last Update Posted : October 12, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Astellas Pharma Inc

Study Description

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

Study Design

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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

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

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.

Contacts and Locations

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

More Information

Additional Information:

Link to results on Astellas Clinical Study Results Web site This link exits the ClinicalTrials.gov site

Publications:

Matsueda K, Harasawa S, Hongo M, Hiwatashi N, Sasaki D. A randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndrome. Scand J Gastroenterol. 2008;43(10):1202-11. doi: 10.1080/00365520802240255.

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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

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