Irritable Bowel SyndromePhase 2NCT00189813
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
A Phase 2 study testing YM060 in people with Irritable Bowel Syndrome, run by Astellas Pharma Inc at 45 sites in 8 countries.
Trial summary
This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- YM060
- How many people
- 691 participants
- Where
- 45 sitesin 8 countries
- Study dates
- Mar 2005to Dec 2005
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS
Who cannot join
- Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
- Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period
Trial locations and contacts
45 sites in 8 countries.
45 sites in 8 countries
Germany14 sites
Study site
Berlin
Study site
Bochum
Study site
Dietzenbach
Study site
Essen
Study site
Frankfurt
Study site
Friedberg
Study site
Hamburg
Study site
Haßloch
Study site
Königstein
Study site
Leipzig
Study site
Mainz
Study site
Marburg
Study site
Potsdam
Study site
Waltershausen
Poland7 sites
Study site
Bialystok
Study site
Bydgoszcz
Study site
Krakow
Study site
Leszno
Study site
Lublin
Study site
Oława
Study site
Warsaw
Czechia6 sites
Study site
České Budějovice
Study site
Hradec Králové
Study site
Ostrava Hrabuvka
Study site
Prague
Study site
Tábor
Study site
Ústí nad Orlicí
Ukraine6 sites
Study site
Dnipropetrovsk
Study site
Kiev
Study site
Lviv
Study site
Odesa
Study site
Simferopol
Study site
Sumy
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome
This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- YM060
- Keywords
- Irritable Bowel Syndrome, Diarrhea, Nasea®, Irribow®, ramosetron
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM060Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Responsible party
- Sponsor
- Investigators
- F. Verbeeck, Study chair, Director of Late Phase Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189813
- Sponsor's protocol ID
- 060-CL-305
- Status last verified
- Aug 2014
- First submitted
- 13 Sep 2005
- Last updated
- 28 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00189813
- Acronym / sponsor ID
- 060-CL-305
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Diarrhea, Nasea®, Irribow®, ramosetron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 19 Sep 2005 (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.
This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS
Key exclusion criteria (2 listed)
- Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
- Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period
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 |
|---|---|---|
| YM060 | Drug | – |
Primary outcome
Not reported in the source record.
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 28 Aug 2014.
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
F. Verbeeck study chair
Director of Late Phase Development
45 sites in 8 countries: 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 45 sites in 8 countries.
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 2 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 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Germany, Poland, Czechia, Ukraine, Bulgaria and 3 more countries. 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.
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.
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 28 Aug 2014.