Overactive BladderPhase 2NCT00337090
A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)
A Phase 2 study testing YM178 in people with Overactive Bladder, run by Astellas Pharma Inc at 84 sites in 15 countries.
Trial summary
The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- YM178
- How many people
- 1,108 participants
- Where
- 84 sitesin 15 countries
- Study dates
- Start not givento Mar 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years suffering from overactive bladder (OAB) for more than 3 months
Who cannot join
- Pregnant and breastfeeding women
- Any medical condition or need for co-medication which interferes with the drug under investigation (YM178) or the comparator (tolterodine)
Trial locations and contacts
84 sites in 15 countries.
84 sites in 15 countries
Germany15 sites
Study site
Bad Ems
Study site
Bamberg
Study site
Bautzen
Study site
Berlin
Study site
Dresden
Study site
Frankfurt
Study site
Hagenow
Study site
Halle
Study site
Hamburg
Study site
Koblenz
Study site
Leipzig
Study site
München
Study site
Radebeul
Study site
Trier
Study site
Uetersen
Italy9 sites
Study site
Catanzaro
Study site
Milan
Study site
Modena
Study site
Padova
Study site
Roma
Study site
Sassari
Study site
Torino
Study site
Udine
Study site
Varese
United Kingdom9 sites
Study site
Birmingham
Study site
Blackburn
Study site
Chichester
Study site
Croydon
Study site
London
Study site
Reading
Study site
Sheffield
Study site
Southampton
Study site
Swansea
Spain8 sites
2 Sites
Barcelona
Study site
Bilbao
2 Sites
Madrid
Study site
Manacor
Study site
Miranda de Ebro
Study site
San Juan de Alica
Study site
Seville
Study site
Vigo
Czechia6 sites
Study site
Brno
Study site
Mělník
Study site
Ostrava
3 Sites
Prague
Study site
Ústí nad Labem
Study site
Zlín
Hungary6 sites
Study site
Miskolc
Study site
Nyíregyháza
Study site
Pécs
Study site
Sopron
Study site
Szeged
Study site
Tatabánya
Netherlands6 sites
Study site
Amsterdam
Study site
Apeldoorn
Study site
Arnhem
Study site
Eindhoven
Study site
Enschede
Study site
Maastricht
Poland6 sites
Study site
Bialystok
Study site
Katowice
Study site
Kielce
Study site
Lublin
3 Sites
Warsaw
3 Sites
Wroclaw
Belgium5 sites
3 Sites
Antwerp
2 Sites
Brussels
Study site
Ghent
Study site
Leuven
Study site
Liège
About this study
Official title: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder
The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.
- Conditions
- Overactive Bladder
- Being tested
- YM178
- Keywords
- Over Active Bladder, Urinary incontinence, YM178, Symptomatic Over Active Bladder
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM178Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Primary completionMar 2007
- Study completionMar 2007
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 Overactive BladderStudies 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
- 1,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Investigators
- Astellas Pharma, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337090
- Sponsor's protocol ID
- 178-CL-044
- Status last verified
- Jul 2013
- First submitted
- 14 Jun 2006
- Last updated
- 2 Jul 2013
- Results posted
- No
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder
- ClinicalTrials.gov ID
- NCT00337090
- Acronym / sponsor ID
- 178-CL-044
- Conditions
- Overactive Bladder
- Keywords
- Over Active Bladder, Urinary incontinence, YM178, Symptomatic Over Active Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,108 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 15 Jun 2006 (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 study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years suffering from overactive bladder (OAB) for more than 3 months
Key exclusion criteria (2 listed)
- Pregnant and breastfeeding women
- Any medical condition or need for co-medication which interferes with the drug under investigation (YM178) or the comparator (tolterodine)
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 |
|---|---|---|
| YM178 | 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 2 Jul 2013.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
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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.
Astellas Pharma study chair
Astellas Pharma Europe B.V.
84 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM178 in people with Overactive Bladder, run by Astellas Pharma Inc at 84 sites in 15 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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in Germany, Italy, United Kingdom, Spain, Czechia and 10 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?
On the ClinicalTrials.gov record for NCT00337090, 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 2 Jul 2013.