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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00337090

Collaborator

Astellas Pharma Europe B.V. (Industry)

1,108

Enrollment

Locations

13.2

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: YM178	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country
1	3 Sites	Antwerp	Belgium
2	2 Sites	Brussels	Belgium
3		Gent	Belgium
4		Leuven	Belgium
5		Liege	Belgium
6		Brno	Czech Republic
7		Melnik	Czech Republic
8		Ostrava	Czech Republic
9	3 Sites	Prague	Czech Republic
10		Usti nad Labem	Czech Republic
11		Zlin	Czech Republic
12		Holbaek	Denmark
13		Kolding	Denmark
14		Roskilde	Denmark
15	2 Sites	Nantes	France
16	2 Sites	Paris	France
17		Bad Ems	Germany
18		Bamberg	Germany
19		Bautzen	Germany
20		Berlin	Germany
21		Dresden	Germany
22		Frankfurt	Germany
23		Hagenow	Germany
24		Halle/Saale	Germany
25		Hamburg	Germany
26		Koblenz	Germany
27		Leipzig	Germany
28		Munchen	Germany
29		Radebeul	Germany
30		Trier	Germany
31		Uetersen	Germany
32	3 Sites	Athens	Greece
33		Patras	Greece
34		Miskolc	Hungary
35		Nyiregyhaza	Hungary
36		Pecs	Hungary
37		Sopron	Hungary
38		Szeged	Hungary
39		Tatabanya	Hungary
40		Catanzaro	Italy
41		Milano	Italy
42		Modena	Italy
43		Padova	Italy
44		Roma	Italy
45		Sassari	Italy
46		Torino	Italy
47		Udine	Italy
48		Varese	Italy
49		Amsterdam	Netherlands
50		Apeldoorn	Netherlands
51		Arnhem	Netherlands
52		Eindhoven	Netherlands
53		Enschede	Netherlands
54		Maastricht	Netherlands
55		Bergen	Norway
56		Oslo	Norway
57		Tonsberg	Norway
58		Bialystok	Poland
59		Katowice	Poland
60		Kielce	Poland
61		Lublin	Poland
62	3 Sites	Warszawa	Poland
63	3 Sites	Wroclaw	Poland
64	7 Sites	Moscow	Russian Federation
65	3 Sites	St Petersburg	Russian Federation
66	2 Sites	Barcelona	Spain
67		Bilbao	Spain
68	2 Sites	Madrid	Spain
69		Manacor	Spain
70		Miranda de Ebro	Spain
71		San Juan de Alica	Spain
72		Sevilla	Spain
73		Vigo	Spain
74		Gothenburg	Sweden
75	2 Sites	Stockholm	Sweden
76		Birmingham	United Kingdom
77		Blackburn	United Kingdom
78		Chichester	United Kingdom
79		Croydon	United Kingdom
80		London	United Kingdom
81		Reading	United Kingdom
82		Sheffield	United Kingdom
83		Southampton	United Kingdom
84		Swansea	United Kingdom