A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)

NCT ID: NCT00337090

Last Updated: 2013-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1108 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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YM178

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years suffering from overactive bladder (OAB) for more than 3 months

Exclusion Criteria

* Pregnant and breastfeeding women
* Any medical condition or need for co-medication which interferes with the drug under investigation (YM178) or the comparator (tolterodine)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Astellas Pharma

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

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3 Sites

Antwerp, , Belgium

Site Status

2 Sites

Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Brno, , Czechia

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Mělník, , Czechia

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Ostrava, , Czechia

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3 Sites

Prague, , Czechia

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Ústí nad Labem, , Czechia

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Zlín, , Czechia

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Holbæk, , Denmark

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Kolding, , Denmark

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Roskilde, , Denmark

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2 Sites

Nantes, , France

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2 Sites

Paris, , France

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Bad Ems, , Germany

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Bamberg, , Germany

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Bautzen, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Frankfurt, , Germany

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Hagenow, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Koblenz, , Germany

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Leipzig, , Germany

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München, , Germany

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Radebeul, , Germany

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Trier, , Germany

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Uetersen, , Germany

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3 Sites

Athens, , Greece

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Pátrai, , Greece

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Sopron, , Hungary

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Szeged, , Hungary

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Tatabánya, , Hungary

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Catanzaro, , Italy

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Milan, , Italy

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Modena, , Italy

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Padua, , Italy

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Roma, , Italy

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Sassari, , Italy

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Torino, , Italy

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Udine, , Italy

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Varese, , Italy

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Amsterdam, , Netherlands

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Apeldoorn, , Netherlands

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Arnhem, , Netherlands

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Eindhoven, , Netherlands

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Enschede, , Netherlands

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Maastricht, , Netherlands

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Bergen, , Norway

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Oslo, , Norway

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Tønsberg, , Norway

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Bialystok, , Poland

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Katowice, , Poland

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Kielce, , Poland

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Lublin, , Poland

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3 Sites

Warsaw, , Poland

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3 Sites

Wroclaw, , Poland

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7 Sites

Moscow, , Russia

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3 Sites

Saint Petersburg, , Russia

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2 Sites

Barcelona, , Spain

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Bilbao, , Spain

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2 Sites

Madrid, , Spain

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Manacor, , Spain

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Miranda de Ebro, , Spain

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San Juan de Alica, , Spain

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Seville, , Spain

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Vigo, , Spain

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Gothenburg, , Sweden

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2 Sites

Stockholm, , Sweden

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Birmingham, , United Kingdom

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Blackburn, , United Kingdom

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Chichester, , United Kingdom

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Croydon, , United Kingdom

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London, , United Kingdom

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Reading, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

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Swansea, , United Kingdom

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Countries

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Belgium Czechia Denmark France Germany Greece Hungary Italy Netherlands Norway Poland Russia Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37160401 (View on PubMed)

Other Identifiers

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178-CL-044

Identifier Type: -

Identifier Source: org_study_id

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