Back to resultsA Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM178
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Over Active Bladder, Urinary incontinence, YM178, Symptomatic Over Active Bladder
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)
Sites / Locations
- 3 Sites
- 2 Sites
- 3 Sites
- 2 Sites
- 2 Sites
- 3 Sites
- 3 Sites
- 3 Sites
- 7 Sites
- 3 Sites
- 2 Sites
- 2 Sites
- 2 Sites
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00337090
First Posted
June 14, 2006
Last Updated
July 1, 2013
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.
1. Study Identification
Unique Protocol Identification Number
NCT00337090
Brief Title
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
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Over Active Bladder, Urinary incontinence, YM178, Symptomatic Over Active Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1108 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM178
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astellas Pharma
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
Facility Name
3 Sites
City
Antwerp
Country
Belgium
Facility Name
2 Sites
City
Brussels
Country
Belgium
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
Facility Name
3 Sites
City
Prague
Country
Czech Republic
City
Usti nad Labem
Country
Czech Republic
City
Zlin
Country
Czech Republic
City
Holbaek
Country
Denmark
City
Kolding
Country
Denmark
City
Roskilde
Country
Denmark
Facility Name
2 Sites
City
Nantes
Country
France
Facility Name
2 Sites
City
Paris
Country
France
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
Facility Name
3 Sites
City
Athens
Country
Greece
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
Facility Name
3 Sites
City
Warszawa
Country
Poland
Facility Name
3 Sites
City
Wroclaw
Country
Poland
Facility Name
7 Sites
City
Moscow
Country
Russian Federation
Facility Name
3 Sites
City
St Petersburg
Country
Russian Federation
Facility Name
2 Sites
City
Barcelona
Country
Spain
City
Bilbao
Country
Spain
Facility Name
2 Sites
City
Madrid
Country
Spain
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
Facility Name
2 Sites
City
Stockholm
Country
Sweden
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
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=657
Description
Link to Results on JAPIC
Learn more about this trial
A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)
We'll reach out to this number within 24 hrs