Irritable Bowel SyndromePhase 2NCT01274000
A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients
A Phase 2 study testing YM060 in people with Irritable Bowel Syndrome, run by Astellas Pharma Inc at 4 sites in Japan.
Trial summary
A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety. Read more about this study
- Who is it for?
- Ages 20 to 64 years, women only
- Conditions the study is for
- 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
- 409 participants
- Where
- 4 sitesJapan
- Study dates
- Nov 2010to Oct 2011
- Phase
- Phase 2
- 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 meeting the Rome III Diagnostic Criteria
- Loose (mushy) or watery stools within the last 3 months
- Abdominal discomfort and/or pain during their non-menstrual period
Who cannot join
- Patients with a history of surgical resection of the stomach, small intestine or large intestine
- Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
- Patients with a history or current diagnosis of colitis ischemic
- Patients with a current diagnosis of enteritis infectious
- Patients with a current diagnosis of hyperthyroidism or hypothyroidism
- Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
- Patients with a history or current diagnosis of malignant tumor
- Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyusyu
About this study
Official title: Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome
A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- YM060, placebo
- Keywords
- diarrhea, IBS, Colonic disease, YM060, Ramosetron
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea, Colonic Diseases
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 |
|---|---|---|
| placebo group | Placebo comparator | Not described Receives: Drug: placebo |
| YM060 low-dose group | Experimental | Not described Receives: Drug: YM060 |
| YM060 middle-dose group | Experimental | Not described Receives: Drug: YM060 |
| YM060 high-dose group | Experimental | Not described Receives: Drug: YM060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate of patients reported global assessment of relief of IBS symptoms
Measured: for 4 weeks
Secondary outcomes (4)
Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain
Measured: for 4 weeks
Responder rate of patients reported assessment of improvement of abnormal bowel habits
Measured: for 4 weeks
Change in weekly average scores of stool form (appearance)
Measured: Baseline and for 4 weeks
Safety assessed by the incidence of adverse events and abnormal values in lab-tests
Measured: for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274000
- Sponsor's protocol ID
- 060-CL-701
- Status last verified
- Oct 2015
- First submitted
- 5 Jan 2011
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fukudo S, Matsueda K, Haruma K, Ida M, Hayase H, Akiho H, Nakashima Y, Hongo M. Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13023. Epub 2017 Feb 16.
PubMed 28205278
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
- Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01274000
- Acronym / sponsor ID
- 060-CL-701
- Conditions
- Irritable Bowel Syndrome
- Keywords
- diarrhea, IBS, Colonic disease, YM060, Ramosetron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Jan 2011 (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.
A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: placebo |
| YM060 low-dose group | Experimental | Drug: YM060 |
| YM060 middle-dose group | Experimental | Drug: YM060 |
| YM060 high-dose group | Experimental | Drug: YM060 |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients meeting the Rome III Diagnostic Criteria
- Loose (mushy) or watery stools within the last 3 months
- Abdominal discomfort and/or pain during their non-menstrual period
Key exclusion criteria (8 listed)
- Patients with a history of surgical resection of the stomach, small intestine or large intestine
- Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
- Patients with a history or current diagnosis of colitis ischemic
- Patients with a current diagnosis of enteritis infectious
- Patients with a current diagnosis of 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 high-dose group, YM060 low-dose group, YM060 middle-dose group |
| placebooral | Drug | placebo group |
Primary outcome
Responder rate of patients reported global assessment of relief of IBS symptoms
Time frame: for 4 weeks
4 secondary outcomes
Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain
Time frame: for 4 weeks
Responder rate of patients reported assessment of improvement of abnormal bowel habits
Time frame: for 4 weeks
Change in weekly average scores of stool form (appearance)
Time frame: Baseline and for 4 weeks
Safety assessed by the incidence of adverse events and abnormal values in lab-tests
Time frame: for 4 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 28205278Fukudo S, Matsueda K, Haruma K, Ida M, Hayase H, Akiho H, Nakashima Y, Hongo M. Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13023. Epub 2017 Feb 16.
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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.
Use Central Contact study chair
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 2 study testing YM060 in people with 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 3 inclusion and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Responder rate of patients reported global assessment of relief of IBS symptoms (time frame: for 4 weeks). 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 NCT01274000, 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.