UK Study Assessing Flexible Dose Fesoterodine in Adults

NCT ID: NCT00806494

Last Updated: 2011-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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To explore the effects of fesoterodine when used in a flexible dose manner

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Fesoterodine 4mg, escalating to 8mg as required

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated

Interventions

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Fesoterodine

Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female \>18 years old
* OAB for \>3 months

Exclusion Criteria

* Patients with conditions that would contraindicate for fesoterodine use
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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

Ely, Cambridgeshire, United Kingdom

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Crewe, Cheshire, United Kingdom

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Fowey, Cornwall, United Kingdom

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Penzance, Cornwall, United Kingdom

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Chesterfield, Derbyshire, United Kingdom

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Chesterfield, Derbyshire, United Kingdom

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Plymouth, Devon, United Kingdom

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Bexhill-on-Sea, East Sussex, United Kingdom

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Baillieston, Glasgow, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Hinckley, Leicestershire, United Kingdom

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West Didsbury, Manchester, United Kingdom

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Ashford, Middlesex, United Kingdom

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Northwood, Middlesex, United Kingdom

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Mortimer, Reading, United Kingdom

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Ayrshire, Scotland, United Kingdom

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Falkirk, Scotland, United Kingdom

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Winterton, Scunthorpe, United Kingdom

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Bath, Somerset, United Kingdom

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Doncaster, South Yorkshire, United Kingdom

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Sheffield, South Yorkshire, United Kingdom

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Addlestone, Surrey, United Kingdom

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Leatherhead, Surrey, United Kingdom

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Worthing, West Sussex, United Kingdom

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Bradford-on-Avon, Wiltshire, United Kingdom

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Chippenham, Wilts, United Kingdom

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Bath, , United Kingdom

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Bath, , United Kingdom

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Bristol, , United Kingdom

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Bucks, , United Kingdom

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Glasgow, , United Kingdom

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Hertfordshire, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Northants, , United Kingdom

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Plymouth, , United Kingdom

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Swansea, , United Kingdom

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Swindon, , United Kingdom

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Countries

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United Kingdom

Related Links

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Other Identifiers

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A0221058

Identifier Type: -

Identifier Source: org_study_id

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