A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01870895
First received: June 4, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Diarrhea-predominant Irritable Bowel Syndrome
Drug: YM060
Drug: Placebo
Phase 3

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: A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Monthly responder rate of global assessment of relief of overall IBS symptoms at final point [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Monthly responder rate of stool form normalization at final point [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monthly responder rate of global assessment of relief of abdominal pain/discomfort [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Monthly responder rate of global assessment of improvement of abnormal bowel habits [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in weekly average scores of severity of abdominal pain/discomfort [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in weekly average scores of stool form [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Safety assessment of YM060 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 577
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM060 group Drug: YM060
oral
Other Names:
  • ramosetron,
  • Irribow
Placebo Comparator: Placebo group Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders 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
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: NCT01870895

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01870895     History of Changes
Other Study ID Numbers: 060-CL-702
Study First Received: June 4, 2013
Last Updated: April 15, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM060
Ramosetron
Diarrhea-predominant Irritable Bowel Syndrome

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014