Study of ONO-8539 in Patients With Overactive Bladder

NCT ID: NCT00876421

Last Updated: 2012-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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P

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo / 12 weeks

A

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

4mg / 12 weeks

E1

Group Type EXPERIMENTAL

ONO-8539

Intervention Type DRUG

low dose / 12 weeks

E2

Group Type EXPERIMENTAL

ONO-8539

Intervention Type DRUG

medium dose / 12 weeks

E3

Group Type EXPERIMENTAL

ONO-8539

Intervention Type DRUG

higher dose / 12 weeks

Interventions

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Placebo

Placebo / 12 weeks

Intervention Type DRUG

Tolterodine

4mg / 12 weeks

Intervention Type DRUG

ONO-8539

low dose / 12 weeks

Intervention Type DRUG

ONO-8539

medium dose / 12 weeks

Intervention Type DRUG

ONO-8539

higher dose / 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomohiro Kuwayama

Role: STUDY_DIRECTOR

Clinical Development, ONO Pharma UK, Ltd

Locations

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Brno, , Czechia

Site Status

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

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Countries

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Czechia Germany Hungary Netherlands Poland Romania Russia Sweden Ukraine

Other Identifiers

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ONO-8539POE004

Identifier Type: -

Identifier Source: org_study_id

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