Study of ONO-8539 in Patients With Overactive Bladder

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT00876421

Collaborator

(none)

435

Enrollment

Locations

Arms

8.7

Patients Per Site

Study Details

Study Description

Brief Summary

The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Placebo Drug: Tolterodine Drug: ONO-8539 Drug: ONO-8539 Drug: ONO-8539	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

435 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: P	Drug: Placebo Placebo / 12 weeks
Active Comparator: A	Drug: Tolterodine 4mg / 12 weeks
Experimental: E1	Drug: ONO-8539 low dose / 12 weeks
Experimental: E2	Drug: ONO-8539 medium dose / 12 weeks
Experimental: E3	Drug: ONO-8539 higher dose / 12 weeks

Outcome Measures

Primary Outcome Measures

Overactive bladder symptoms [12 weeks]

Secondary Outcome Measures

Overactive bladder symptoms (QOL) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with medical history of Overactive Bladder symptoms for > 6 months

Exclusion Criteria:

Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

Contacts and Locations

Locations

	City	Country
1	Brno	Czech Republic
2	Jindrichuv Hradec	Czech Republic
3	Olomouc	Czech Republic
4	Opava	Czech Republic
5	Plzen	Czech Republic
6	Praha	Czech Republic
7	Steti	Czech Republic
8	Usti Nad Labem	Czech Republic
9	Duisburg	Germany
10	Hagenow	Germany
11	Krumbach	Germany
12	Magdeburg	Germany
13	Mulheim	Germany
14	Weiden	Germany
15	Budapest	Hungary
16	Dombovar	Hungary
17	Nyiregyhaza	Hungary
18	Szeged	Hungary
19	Szekszard	Hungary
20	Den Haag	Netherlands
21	Heerlen	Netherlands
22	Maastricht	Netherlands
23	Tilburg	Netherlands
24	Winterswijk	Netherlands
25	Bialystok	Poland
26	Bielsko-Biala	Poland
27	Gdansk	Poland
28	Gdynia	Poland
29	Katowice	Poland
30	Lodz	Poland
31	Lublin	Poland
32	Myslowice	Poland
33	Warszawa	Poland
34	Arad	Romania
35	Bihor	Romania
36	Bucharest	Romania
37	Timis	Romania
38	Moscow	Russian Federation
39	Rostov-on-Don	Russian Federation
40	St. Petersburg	Russian Federation
41	Goteborg	Sweden
42	Kungalv	Sweden
43	Stockholm	Sweden
44	Umea	Sweden
45	Uppsala	Sweden
46	Chernivtsi	Ukraine
47	Donetsk	Ukraine
48	Kharkiv	Ukraine
49	Kyiv	Ukraine
50	Zaporizhzhya	Ukraine