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NCT Number: NCT01225237

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hokkaido, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramosetron

Drug

oral

Other names: Irribow, YM060

Placebo

Drug

oral

Primary outcomes

  1. Responder rate of stool form normalization

    Time frame: For 4 weeks

Secondary outcomes

  1. Responder rate of patients reported global assessment of relief of IBS symptoms

    Time frame: For 4 weeks

  2. Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain

    Time frame: For 4 weeks

  3. Responder rate of patients reported assessment of improvement of abnormal bowel habits

    Time frame: For 4 weeks

  4. Safety assessed by the incidence of adverse events and abnormal values in labo-tests

    Time frame: For 4 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2010
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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