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

October 19, 2010
September 19, 2011
October 2010
August 2011   (final data collection date for primary outcome measure)
Responder rate of stool form normalization [ Time Frame: For 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01225237 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients
Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - Double-blind, Parallel-group Comparative Study in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Drug: Ramosetron
    oral
    Other Names:
    • Irribow
    • YM060
  • Drug: Placebo
    oral
  • Experimental: ramosetron group
    Intervention: Drug: Ramosetron
  • Placebo Comparator: Placebo group
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
296
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Male
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01225237
060-CL-501
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP