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OpenTrials
Completed

NCT Number: NCT02612649

Special Drug Use Surveillance of Irribow in Female Patients

The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.

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Key information

Conditions

Diarrhea-predominant Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Sex eligibility

Female

Study type

Observational

Primary location

Numakunai, Iwate, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion criteria

-

Treatment and study plan

Ramosetron

Drug

Oral

Other names: YM060, Irribow

Primary outcomes

  1. Incidences of Adverse Drug Reactions

    Time frame: Up to Week 52

Secondary outcomes

  1. Change from baseline in frequency of bowel movements

    Time frame: Baseline to Week 52

    Frequency of bowel movements is recorded daily

  2. Change from baseline in form of stool

    Time frame: Baseline to Week 52

    Classified based on Bristol Stool Form Scale

  3. Change from baseline in sensation of incomplete bowel evacuation

    Time frame: Baseline to Week 52

    Assessment based on numerical rating scale

  4. Change from baseline in defecation urgency

    Time frame: Baseline to Week 52

  5. Change from baseline in abdominal pain or discomfort

    Time frame: Baseline to Week 52

    Abdominal pain or discomfort assessed based on numerical rating scale

  6. Change from baseline in melena

    Time frame: Baseline to Week 52

  7. Overall improvement

    Time frame: Up to Week 52

    Classified into the three scales (improved, no change or aggravated) or concluded as indeterminable.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2015
Registry last updated
Oct 21, 2024

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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