Diarrhea-predominant Irritable Bowel SyndromeNCT02612649
Special Drug Use Surveillance of Irribow in Female Patients
An observational study of Diarrhea-predominant Irritable Bowel Syndrome, run by Astellas Pharma Inc at 34 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- Ramosetron
- Type of treatment
- Pill or oral medicine
- How many people
- 793 participants
- Where
- 34 sitesJapan
- Study dates
- 1 Oct 2015to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients with diarrhea-predominant irritable bowel syndrome
Who may be able to join
- Female patients with diarrhea-predominant irritable bowel syndrome
Who cannot join
- -
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
Study site
Aichi
Study site
Akita
Study site
Chiba
Study site
Fukui
Study site
Fukuoka
Study site
Fukushima
Study site
Gifu
Study site
Gunma
Study site
Hiroshima
Study site
Hyōgo
Study site
Ibaraki
Study site
Kagoshima
Study site
Kanagawa
Study site
Kumamoto
Study site
Kyoto
Study site
Mie
Study site
Miyagi
Study site
Miyazaki
Study site
Nagano
Study site
Niigata
Study site
Numakunai, Iwate
Study site
Ōita
Study site
Okayama
Study site
Okinawa
Study site
Osaka
Study site
Saitama
Study site
Shiga
Study site
Shizuoka
Study site
Tochigi
Study site
Tokyo
Study site
Tottori
Study site
Toyama
Study site
Yamagata
Study site
Yamaguchi
About this study
Official title: Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets 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.
- Being tested
- Ramosetron
- Keywords
- Irritable bowel syndrome, YM060, Ramosetron, Survey
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
Also called YM060, Irribow
Oral
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron group | Female patients with diarrhea-predominant irritable bowel syndrome Receives: Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Adverse Drug Reactions
Measured: Up to Week 52
Secondary outcomes (7)
Change from baseline in frequency of bowel movements
Frequency of bowel movements is recorded daily
Measured: Baseline to Week 52
Change from baseline in form of stool
Classified based on Bristol Stool Form Scale
Measured: Baseline to Week 52
Change from baseline in sensation of incomplete bowel evacuation
Assessment based on numerical rating scale
Measured: Baseline to Week 52
Change from baseline in defecation urgency
Measured: Baseline to Week 52
Change from baseline in abdominal pain or discomfort
Abdominal pain or discomfort assessed based on numerical rating scale
Measured: Baseline to Week 52
Change from baseline in melena
Measured: Baseline to Week 52
Overall improvement
Classified into the three scales (improved, no change or aggravated) or concluded as indeterminable.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start1 Oct 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612649
- Sponsor's protocol ID
- IB0002
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2015
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients
- ClinicalTrials.gov ID
- NCT02612649
- Acronym / sponsor ID
- IB0002
- Keywords
- Irritable bowel syndrome, YM060, Ramosetron, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramosetron group | – | Drug: RamosetronFemale patients with diarrhea-predominant irritable bowel syndrome |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients with diarrhea-predominant irritable bowel syndrome
Key inclusion criteria (1 listed)
- Female patients with diarrhea-predominant irritable bowel syndrome
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamosetronAlso: YM060, IrribowOral | Drug | Ramosetron group |
Primary outcome
Incidences of Adverse Drug Reactions
Time frame: Up to Week 52
7 secondary outcomes
Change from baseline in frequency of bowel movements
Time frame: Baseline to Week 52
Change from baseline in form of stool
Time frame: Baseline to Week 52
Change from baseline in sensation of incomplete bowel evacuation
Time frame: Baseline to Week 52
Change from baseline in defecation urgency
Time frame: Baseline to Week 52
Change from baseline in abdominal pain or discomfort
Time frame: Baseline to Week 52
Change from baseline in melena
Time frame: Baseline to Week 52
Overall improvement
Time frame: Up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea-predominant Irritable Bowel Syndrome, run by Astellas Pharma Inc at 34 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of Adverse Drug Reactions (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.