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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01274000
First received: January 5, 2011
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
Drug: YM060
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Responder rate of patients reported global assessment of relief of IBS symptoms [ Time Frame: for 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain [ Time Frame: for 4 weeks ] [ Designated as safety issue: No ]
  • Responder rate of patients reported assessment of improvement of abnormal bowel habits [ Time Frame: for 4 weeks ] [ Designated as safety issue: No ]
  • Change in weekly average scores of stool form (appearance) [ Time Frame: Baseline and for 4 weeks ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events and abnormal values in lab-tests [ Time Frame: for 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 409
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01274000     History of Changes
Other Study ID Numbers: 060-CL-701
Study First Received: January 5, 2011
Last Updated: October 14, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Ramosetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014