Clinical trial NCT00806494: UK Study Assessing Flexible Dose Fesoterodine in Adults
Official title: A 12 Week, Multi-centre, Open Label Study To Evaluate The Efficacy, Tolerability And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: Fesoterodine
Open Label
Flexible Dose
OAB
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4
timeFrame: Baseline, Week 4
measure: Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
timeFrame: Week 12 (or Early Withdrawal)
measure: Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12
timeFrame: Week 12 (or Early Withdrawal)
measure: Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Ely
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambridgeshire
city: Crewe
country: United Kingdom
facility: Pfizer Investigational Site
state: Cheshire
city: Fowey
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Penzance
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Chesterfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Derbyshire
city: Chesterfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Derbyshire
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Bexhill on Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Baillieston
country: United Kingdom
facility: Pfizer Investigational Site
state: Glasgow
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Hinckley
country: United Kingdom
facility: Pfizer Investigational Site
state: Leicestershire
city: West Didsbury
country: United Kingdom
facility: Pfizer Investigational Site
state: Manchester
city: Ashford
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Northwood
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Mortimer
country: United Kingdom
facility: Pfizer Investigational Site
state: Reading
city: Ayrshire
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Falkirk
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Winterton
country: United Kingdom
facility: Pfizer Investigational Site
state: Scunthorpe
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: Doncaster
country: United Kingdom
facility: Pfizer Investigational Site
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: South Yorkshire
city: Addlestone
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Leatherhead
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Worthing
country: United Kingdom
facility: Pfizer Investigational Site
state: West Sussex
city: Bradford-on-Avon
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Chippenham
country: United Kingdom
facility: Pfizer Investigational Site
state: Wilts
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Bucks
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Hertfordshire
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Northants
country: United Kingdom
facility: Pfizer Investigational Site
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
city: Swansea
country: United Kingdom
facility: Pfizer Investigational Site
city: Swindon
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: