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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2011

Interventions

  • Drug: Ramosetron
    • oral
  • Drug: Placebo
    • oral

Arms, Groups and Cohorts

  • Experimental: ramosetron group
  • Placebo Comparator: Placebo group

Clinical Trial Outcome Measures

Primary Measures

  • Responder rate of stool form normalization
    • Time Frame: For 4 weeks

Secondary Measures

  • Responder rate of patients reported global assessment of relief of IBS symptoms
    • Time Frame: For 4 weeks
  • Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain
    • Time Frame: For 4 weeks
  • Responder rate of patients reported assessment of improvement of abnormal bowel habits
    • Time Frame: For 4 weeks
  • Safety assessed by the incidence of adverse events and abnormal values in labo-tests
    • Time Frame: For 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Use Central Contact, Study Chair, Astellas Pharma Inc

References

Fukudo S, Ida M, Akiho H, Nakashima Y, Matsueda K. Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea. Clin Gastroenterol Hepatol. 2014 Jun;12(6):953-9.e4. doi: 10.1016/j.cgh.2013.11.024. Epub 2013 Dec 4.

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