Clinical trial NCT00876421: Study of ONO-8539 in Patients With Overactive Bladder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: ONO-8539
Overactive bladder
OAB
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overactive bladder symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Overactive bladder symptoms (QOL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Jindrichuv Hradec
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Opava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha
country: Czech Republic
city: Steti
country: Czech Republic
city: Usti Nad Labem
country: Czech Republic
city: Duisburg
country: Germany
city: Hagenow
country: Germany
city: Krumbach
country: Germany
city: Magdeburg
country: Germany
city: Mulheim
country: Germany
city: Weiden
country: Germany
city: Budapest
country: Hungary
city: Dombovar
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
country: Hungary
city: Den Haag
country: Netherlands
city: Heerlen
country: Netherlands
city: Maastricht
country: Netherlands
city: Tilburg
country: Netherlands
city: Winterswijk
country: Netherlands
city: Bialystok
country: Poland
city: Bielsko-Biala
country: Poland
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Myslowice
country: Poland
city: Warszawa
country: Poland
city: Arad
country: Romania
city: Bihor
country: Romania
city: Bucharest
country: Romania
city: Timis
country: Romania
city: Moscow
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Goteborg
country: Sweden
city: Kungalv
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Chernivtsi
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Clinical Development, ONO Pharma UK, Ltd
name: Tomohiro Kuwayama
role: STUDY_DIRECTOR
References: