Diarrhea-predominant Irritable Bowel SyndromePhase 3NCT01870895
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
A Phase 3 study testing YM060 in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Astellas Pharma Inc at 4 sites in Japan.
Trial summary
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS). Read more about this study
- Who is it for?
- Ages 20 to 64 years, women only
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- YM060
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 577 participants
- Where
- 4 sitesJapan
- Study dates
- Feb 2013to Feb 2014
- Phase
- Phase 3
- 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 20 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients satisfying the Rome III Diagnostic Criteria
- Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
- Patients who have abdominal pain or discomfort
- Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema
Who cannot join
- Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
- Patients with a history or current evidence of inflammatory bowel disease
- Patients with a history or current evidence of colitis ischemic
- Patients with concurrent infectious enteritis
- Patients with concurrent hyperthyroidism or hypothyroidism
- Patients with concurrent active peptic ulcer
- Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
About this study
Official title: A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
- Being tested
- YM060, Placebo
- Keywords
- YM060, Ramosetron, Diarrhea-predominant Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM060Drug
Also called ramosetron,, Irribow
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| YM060 group | Experimental | Not described Receives: Drug: YM060 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
Measured: Up to 12 weeks
Monthly responder rate of stool form normalization at final point
Measured: Up to 12 weeks
Secondary outcomes (5)
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Measured: Up to 12 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Measured: Up to 12 weeks
Change in weekly average scores of severity of abdominal pain/discomfort
Measured: Up to 12 weeks
Change in weekly average scores of stool form
Measured: Up to 12 weeks
Safety assessment of YM060
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 577 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
- NCT01870895
- Sponsor's protocol ID
- 060-CL-702
- Status last verified
- Oct 2015
- First submitted
- 4 Jun 2013
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb;150(2):358-66.e8. doi: 10.1053/j.gastro.2015.10.047. Epub 2015 Nov 6.
PubMed 26551550
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01870895
- Acronym / sponsor ID
- 060-CL-702
- Keywords
- YM060, Ramosetron, Diarrhea-predominant Irritable Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Jun 2013 (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.
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YM060 group | Experimental | Drug: YM060 |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients satisfying the Rome III Diagnostic Criteria
- Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
- Patients who have abdominal pain or discomfort
- Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema
Key exclusion criteria (7 listed)
- Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
- Patients with a history or current evidence of inflammatory bowel disease
- Patients with a history or current evidence of colitis ischemic
- Patients with concurrent infectious enteritis
- Patients with concurrent hyperthyroidism or hypothyroidism
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 |
|---|---|---|
| YM060Also: ramosetron,, Irriboworal | Drug | YM060 group |
| Placebooral | Drug | Placebo group |
Primary outcome
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
Time frame: Up to 12 weeks
Monthly responder rate of stool form normalization at final point
Time frame: Up to 12 weeks
5 secondary outcomes
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Time frame: Up to 12 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Time frame: Up to 12 weeks
Change in weekly average scores of severity of abdominal pain/discomfort
Time frame: Up to 12 weeks
Change in weekly average scores of stool form
Time frame: Up to 12 weeks
Safety assessment of YM060
Time frame: Up to 12 weeks
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 12 Oct 2015.
- Derived from this study: PubMed 26551550Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb;150(2):358-66.e8. doi: 10.1053/j.gastro.2015.10.047. Epub 2015 Nov 6.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YM060 in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Astellas Pharma Inc at 4 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 4 inclusion and 7 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01870895, which also lists 1 linked publication.
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 12 Oct 2015.