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A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

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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

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
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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


  Show 45 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Investigators
Study Chair: F. Verbeeck Director of Late Phase Development

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00189813     History of Changes
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:
Syndrome
Diarrhea
Irritable Bowel Syndrome
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