Clinical trial NCT00337090: A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: Over Active Bladder
Urinary incontinence
YM178
Symptomatic Over Active Bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2006-06-15
Enrollment: 1108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: 3 Sites
city: Brussels
country: Belgium
facility: 2 Sites
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Brno
country: Czech Republic
city: Melnik
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Prague
country: Czech Republic
facility: 3 Sites
city: Usti nad Labem
country: Czech Republic
city: Zlin
country: Czech Republic
city: Holbaek
country: Denmark
city: Kolding
country: Denmark
city: Roskilde
country: Denmark
city: Nantes
country: France
facility: 2 Sites
city: Paris
country: France
facility: 2 Sites
city: Bad Ems
country: Germany
city: Bamberg
country: Germany
city: Bautzen
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Frankfurt
country: Germany
city: Hagenow
country: Germany
city: Halle/Saale
country: Germany
city: Hamburg
country: Germany
city: Koblenz
country: Germany
city: Leipzig
country: Germany
city: Munchen
country: Germany
city: Radebeul
country: Germany
city: Trier
country: Germany
city: Uetersen
country: Germany
city: Athens
country: Greece
facility: 3 Sites
city: Patras
country: Greece
city: Miskolc
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Sopron
country: Hungary
city: Szeged
country: Hungary
city: Tatabanya
country: Hungary
city: Catanzaro
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Varese
country: Italy
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Arnhem
country: Netherlands
city: Eindhoven
country: Netherlands
city: Enschede
country: Netherlands
city: Maastricht
country: Netherlands
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Tonsberg
country: Norway
city: Bialystok
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
facility: 3 Sites
city: Wroclaw
country: Poland
facility: 3 Sites
city: Moscow
country: Russian Federation
facility: 7 Sites
city: St Petersburg
country: Russian Federation
facility: 3 Sites
city: Barcelona
country: Spain
facility: 2 Sites
city: Bilbao
country: Spain
city: Madrid
country: Spain
facility: 2 Sites
city: Manacor
country: Spain
city: Miranda de Ebro
country: Spain
city: San Juan de Alica
country: Spain
city: Sevilla
country: Spain
city: Vigo
country: Spain
city: Gothenburg
country: Sweden
city: Stockholm
country: Sweden
facility: 2 Sites
city: Birmingham
country: United Kingdom
city: Blackburn
country: United Kingdom
city: Chichester
country: United Kingdom
city: Croydon
country: United Kingdom
city: London
country: United Kingdom
city: Reading
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Southampton
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Astellas Pharma
role: STUDY_CHAIR
References: