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A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

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ClinicalTrials.gov Identifier: NCT01274000
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome
Study Start Date : November 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo group Drug: placebo
oral
Experimental: YM060 low-dose group Drug: YM060
oral
Other Name: ramosetron, Irribow
Experimental: YM060 middle-dose group Drug: YM060
oral
Other Name: ramosetron, Irribow
Experimental: YM060 high-dose group Drug: YM060
oral
Other Name: ramosetron, Irribow


Outcome Measures

Primary Outcome Measures :
  1. Responder rate of patients reported global assessment of relief of IBS symptoms [ Time Frame: for 4 weeks ]

Secondary Outcome Measures :
  1. Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain [ Time Frame: for 4 weeks ]
  2. Responder rate of patients reported assessment of improvement of abnormal bowel habits [ Time Frame: for 4 weeks ]
  3. Change in weekly average scores of stool form (appearance) [ Time Frame: Baseline and for 4 weeks ]
  4. Safety assessed by the incidence of adverse events and abnormal values in lab-tests [ Time Frame: for 4 weeks ]

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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meeting the Rome III Diagnostic Criteria
  • Loose (mushy) or watery stools within the last 3 months
  • Abdominal discomfort and/or pain during their non-menstrual period

Exclusion Criteria:

  • Patients with a history of surgical resection of the stomach, small intestine or large intestine
  • Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
  • Patients with a history or current diagnosis of colitis ischemic
  • Patients with a current diagnosis of enteritis infectious
  • Patients with a current diagnosis of hyperthyroidism or hypothyroidism
  • Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
  • Patients with a history or current diagnosis of malignant tumor
  • Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them
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): NCT01274000


Locations
Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01274000     History of Changes
Other Study ID Numbers: 060-CL-701
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Astellas Pharma Inc:
diarrhea
IBS
Colonic disease
YM060
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