Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder

NCT ID: NCT00479505

Last Updated: 2011-03-23

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

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-06-30

Brief Summary

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This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active

Group Type EXPERIMENTAL

UK-369,003

Intervention Type DRUG

UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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UK-369,003

UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects aged 18 years and above
* documented clinical diagnosis of overactive bladder with urinary frequency \>= 8 times / 24 hours and number of urgency episodes \> 1 episode / 24 hours.

Exclusion Criteria

* Neurological diseases known to affect bladder function.
* Urinary tract infection.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Miranda, New South Wales, Australia

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Kippa-Ring, Queensland, Australia

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Victoria, British Columbia, Canada

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Barrie, Ontario, Canada

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Kitchener, Ontario, Canada

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Toronto, Ontario, Canada

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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile

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Santiago, RM, Chile

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Santiago, RM, Chile

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Medellín, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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Helsinki, , Finland

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Kouvola, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Turku, , Finland

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Garches, , France

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Lyon, , France

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Montpellier, , France

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Paris, , France

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Rennes, , France

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Frankfurt, , Germany

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Marburg, , Germany

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Muelheim A.d. Ruhr, , Germany

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München, , Germany

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Rosenheim, , Germany

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Cholargós, Athens, Greece

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Epirus, Ioannina, Greece

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Rio, Patras, Greece

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Cefalù, Palermo, Italy

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Florence, , Italy

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Latina, , Italy

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Riga, , Latvia

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Moelv, , Norway

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Oslo, , Norway

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Mysłowice, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Szczecin, , Poland

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Szczecin, , Poland

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Wroclaw, , Poland

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Bratislava, Slovakia, Slovakia

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Martin, Slovakia, Slovakia

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Trenčín, Slovakia, Slovakia

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Košice, , Slovakia

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Sabadell, Barcelona, Spain

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Manacor, Palma de Mallorca, Spain

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Aarau, , Switzerland

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Zurich, , Switzerland

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High Heaton, Newcastle upon Tyne, United Kingdom

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Taunton, Somerset, United Kingdom

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Leeds, , United Kingdom

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Countries

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Australia Canada Chile Colombia Finland France Germany Greece Italy Latvia Norway Poland Slovakia Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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A3711047

Identifier Type: -

Identifier Source: org_study_id

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