NCT00337090

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,108

participants targeted

Target at P75+ for phase_2

Geographic Reach
15 countries

84 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

First QC Date

June 14, 2006

Last Update Submit

July 1, 2013

Conditions

Keywords

Over Active BladderUrinary incontinenceYM178Symptomatic Over Active Bladder

Interventions

YM178DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (84)

3 Sites

Antwerp, Belgium

Location

2 Sites

Brussels, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

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Liège, Belgium

Location

Unknown Facility

Brno, Czechia

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Mělník, Czechia

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Unknown Facility

Ostrava, Czechia

Location

3 Sites

Prague, Czechia

Location

Unknown Facility

Ústí nad Labem, Czechia

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Zlín, Czechia

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Holbæk, Denmark

Location

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Kolding, Denmark

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Roskilde, Denmark

Location

2 Sites

Nantes, France

Location

2 Sites

Paris, France

Location

Unknown Facility

Bad Ems, Germany

Location

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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

Location

3 Sites

Athens, Greece

Location

Unknown Facility

Pátrai, Greece

Location

Unknown Facility

Miskolc, Hungary

Location

Unknown Facility

Nyíregyháza, Hungary

Location

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Pécs, Hungary

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Sopron, Hungary

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Szeged, Hungary

Location

Unknown Facility

Tatabánya, Hungary

Location

Unknown Facility

Catanzaro, Italy

Location

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Milan, Italy

Location

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Modena, Italy

Location

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Padua, Italy

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Sassari, Italy

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Torino, Italy

Location

Unknown Facility

Udine, Italy

Location

Unknown Facility

Varese, Italy

Location

Unknown Facility

Amsterdam, Netherlands

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Unknown Facility

Apeldoorn, Netherlands

Location

Unknown Facility

Arnhem, Netherlands

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Unknown Facility

Eindhoven, Netherlands

Location

Unknown Facility

Enschede, Netherlands

Location

Unknown Facility

Maastricht, Netherlands

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Unknown Facility

Bergen, Norway

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Tønsberg, Norway

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Kielce, Poland

Location

Unknown Facility

Lublin, Poland

Location

3 Sites

Warsaw, Poland

Location

3 Sites

Wroclaw, Poland

Location

7 Sites

Moscow, Russia

Location

3 Sites

Saint Petersburg, Russia

Location

2 Sites

Barcelona, Spain

Location

Unknown Facility

Bilbao, Spain

Location

2 Sites

Madrid, Spain

Location

Unknown Facility

Manacor, Spain

Location

Unknown Facility

Miranda de Ebro, Spain

Location

Unknown Facility

San Juan de Alica, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Vigo, Spain

Location

Unknown Facility

Gothenburg, Sweden

Location

2 Sites

Stockholm, Sweden

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Blackburn, United Kingdom

Location

Unknown Facility

Chichester, United Kingdom

Location

Unknown Facility

Croydon, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Reading, United Kingdom

Location

Unknown Facility

Sheffield, United Kingdom

Location

Unknown Facility

Southampton, United Kingdom

Location

Unknown Facility

Swansea, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Study Officials

  • Astellas Pharma

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 15, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations