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A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (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: NCT01870895
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Condition or disease Intervention/treatment Phase
Diarrhea-predominant Irritable Bowel Syndrome Drug: YM060 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
Experimental: YM060 group Drug: YM060
oral
Other Names:
  • ramosetron,
  • Irribow
Placebo Comparator: Placebo group Drug: Placebo
oral


Outcome Measures
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Primary Outcome Measures :
  1. Monthly responder rate of global assessment of relief of overall IBS symptoms at final point [ Time Frame: Up to 12 weeks ]
  2. Monthly responder rate of stool form normalization at final point [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Monthly responder rate of global assessment of relief of abdominal pain/discomfort [ Time Frame: Up to 12 weeks ]
  2. Monthly responder rate of global assessment of improvement of abnormal bowel habits [ Time Frame: Up to 12 weeks ]
  3. Change in weekly average scores of severity of abdominal pain/discomfort [ Time Frame: Up to 12 weeks ]
  4. Change in weekly average scores of stool form [ Time Frame: Up to 12 weeks ]
  5. Safety assessment of YM060 [ Time Frame: Up to 12 weeks ]

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

Inclusion Criteria:

  1. Patients satisfying the Rome III Diagnostic Criteria
  2. Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
  3. Patients who have abdominal pain or discomfort
  4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion Criteria:

  1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
  2. Patients with a history or current evidence of inflammatory bowel disease
  3. Patients with a history or current evidence of colitis ischemic
  4. Patients with concurrent infectious enteritis
  5. Patients with concurrent hyperthyroidism or hypothyroidism
  6. Patients with concurrent active peptic ulcer
  7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort
Contacts and Locations
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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): NCT01870895


Locations
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Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01870895    
Other Study ID Numbers: 060-CL-702
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by Astellas Pharma Inc:
YM060
Ramosetron
Diarrhea-predominant Irritable Bowel Syndrome
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
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