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A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01225237
First received: October 19, 2010
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: Ramosetron
Drug: Placebo
 Phase 4

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: Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - Double-blind, Parallel-group Comparative Study in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Responder rate of stool form normalization [ Time Frame: For 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate of patients reported global assessment of relief of IBS symptoms [ Time Frame: For 4 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Safety assessed by the incidence of adverse events and abnormal values in labo-tests [ Time Frame: For 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 296
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ramosetron group Drug: Ramosetron
oral
Other Names:
  • Irribow
  • YM060
Placebo Comparator: Placebo group Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meeting the Rome III Diagnostic Criteria
  • Loose (mushy) or watery stools within the last 3 months

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225237

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01225237     History of Changes
Other Study ID Numbers: 060-CL-501
Study First Received: October 19, 2010
Last Updated: September 19, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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 May 23, 2013