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Special Drug Use Surveillance of Irribow in Female Patients

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ClinicalTrials.gov Identifier: NCT02612649
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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.

Condition or disease Intervention/treatment
Diarrhea-predominant Irritable Bowel Syndrome Drug: Ramosetron

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Study Type : Observational
Actual Enrollment : 793 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Group/Cohort Intervention/treatment
Ramosetron group
Female patients with diarrhea-predominant irritable bowel syndrome
Drug: Ramosetron
Oral
Other Names:
  • YM060
  • Irribow




Primary Outcome Measures :
  1. Incidences of Adverse Drug Reactions [ Time Frame: Up to Week 52 ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients with diarrhea-predominant irritable bowel syndrome
Criteria

Inclusion Criteria:

  • Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612649


Locations
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Japan
Aichi, Japan
Akita, Japan
Chiba, Japan
Fukui, Japan
Fukuoka, Japan
Fukushima, Japan
Gifu, Japan
Gunma, Japan
Hiroshima, Japan
Hyogo, Japan
Ibaraki, Japan
Iwate, Japan
Kagoshima, Japan
Kanagawa, Japan
Kumamoto, Japan
Kyoto, Japan
Mie, Japan
Miyagi, Japan
Miyazaki, Japan
Nagano, Japan
Niigata, Japan
Oita, Japan
Okayama, Japan
Okinawa, Japan
Osaka, Japan
Saitama, Japan
Shiga, Japan
Shizuoka, Japan
Tochigi, Japan
Tokyo, Japan
Tottori, Japan
Toyama, Japan
Yamagata, Japan
Yamaguchi, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02612649     History of Changes
Other Study ID Numbers: IB0002
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc:
Irritable bowel syndrome
YM060
Ramosetron
Survey
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action