Study of ONO-8539 in Patients With Overactive Bladder
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
1 other identifier
interventional
435
9 countries
50
Brief Summary
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedJune 14, 2012
June 1, 2012
1 year
April 2, 2009
June 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overactive bladder symptoms
12 weeks
Secondary Outcomes (1)
Overactive bladder symptoms (QOL)
12 weeks
Study Arms (5)
P
PLACEBO COMPARATORA
ACTIVE COMPARATORE1
EXPERIMENTALE2
EXPERIMENTALE3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with medical history of Overactive Bladder symptoms for \> 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Unknown Facility
Brno, Czechia
Unknown Facility
Jindřichův Hradec, Czechia
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Olomouc, Czechia
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Opava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Štětí, Czechia
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Ústí nad Labem, Czechia
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Duisburg, Germany
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Hagenow, Germany
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Krumbach, Germany
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Magdeburg, Germany
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Mülheim, Germany
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Weiden, Germany
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Budapest, Hungary
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Dombóvár, Hungary
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Nyíregyháza, Hungary
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Szeged, Hungary
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Szekszárd, Hungary
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Heerlen, Netherlands
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Maastricht, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Winterswijk, Netherlands
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Bialystok, Poland
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Bielsko-Biala, Poland
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Gdansk, Poland
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Gdynia, Poland
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Katowice, Poland
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Lodz, Poland
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Lublin, Poland
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Mysłowice, Poland
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Warsaw, Poland
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Arad, Romania
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Bihor, Romania
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Bucharest, Romania
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Timuș, Romania
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Moscow, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Gothenburg, Sweden
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Kungälv, Sweden
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Stockholm, Sweden
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Umeå, Sweden
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Uppsala, Sweden
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Chernivtsi, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Zaporizhzhya, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomohiro Kuwayama
Clinical Development, ONO Pharma UK, Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 6, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2010
Last Updated
June 14, 2012
Record last verified: 2012-06