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A Study of YM060 in 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: NCT00189813
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 28, 2014
Sponsor:
Collaborator:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: YM060 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

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:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00189813


Locations
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Bulgaria
Plovdiv, Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Czech Republic
Ceske Budejovice, Czech Republic
Hradec Kralove, Czech Republic
Ostrava Hrabuvka, Czech Republic
Praha, Czech Republic
Tabor, Czech Republic
Usti nad Orlici, Czech Republic
Estonia
Tallinn, Estonia
Tartu, Estonia
Viljandi, Estonia
Germany
Berlin, Germany
Bochum, Germany
Dietzenbach, Germany
Essen, Germany
Frankfurt, Germany
Friedberg, Germany
Hamburg, Germany
Hassloch, Germany
Koenigstein, Germany
Leipzig, Germany
Mainz, Germany
Marburg, Germany
Potsdam, Germany
Waltershausen, Germany
Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania
Vilnius, Lithuania
Poland
Bialystok, Poland
Bydgoszcz, Poland
Krakow, Poland
Leszno, Poland
Lublin, Poland
Olawa, Poland
Warszawa, Poland
Russian Federation
Moscow, Russian Federation
St. Petersburg, Russian Federation
Yaroslavl, Russian Federation
Ukraine
Dnipropetrovsk, Ukraine
Kiev, Ukraine
Lviv, Ukraine
Odessa, Ukraine
Simferopol, Ukraine
Sumy, Ukraine
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Investigators
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Study Chair: F. Verbeeck Director of Late Phase Development

Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00189813    
Other Study ID Numbers: 060-CL-305
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc:
Irritable Bowel Syndrome
Diarrhea
Nasea®
Irribow®
ramosetron
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action