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Completed

NCT Number: NCT00918411

A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).

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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 having hyperthyroidism or hypothyroidism

Treatment and study plan

Ramosetron

Drug

oral

Other names: Irribow, YM060

Placebo

Drug

oral

Primary outcomes

  1. IBS severity index (Japanese version)

    Time frame: 12 weeks

Secondary outcomes

  1. Patient reported global assessment of relief of IBS symptoms

    Time frame: 12 weeks

  2. Patient reported assessment of relief of abdominal discomfort and/or pain

    Time frame: 12 weeks

  3. Patient reported assessment of improvement of abdominal bowel habits

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 11, 2009
Registry last updated
Oct 12, 2015

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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