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UK Study Assessing Flexible Dose Fesoterodine in Adults (SAFINA)

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Fesoterodine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Fesoterodine, Open Label, Flexible Dose, OAB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Fesoterodine 4mg, escalating to 8mg as required

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.

Secondary Outcome Measures

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4
The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.
Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12
Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12
UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement.
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12
Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12
Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.
Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12
Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12
NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement.
Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12
Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12
SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.
Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12
Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12
The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12
OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12
ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).
Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12
TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'.
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.

Full Information

First Posted
December 9, 2008
Last Updated
January 4, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00806494
Brief Title
UK Study Assessing Flexible Dose Fesoterodine in Adults
Acronym
SAFINA
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Fesoterodine, Open Label, Flexible Dose, OAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Fesoterodine 4mg, escalating to 8mg as required
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Intervention Description
Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Description
The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4
Description
The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.
Time Frame
Baseline, Week 4
Title
Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12
Description
Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Description
Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.
Time Frame
Baseline, Week 4 and Week 12
Title
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Description
Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12
Description
UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement.
Time Frame
Baseline, Week 4 and Week 12
Title
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12
Description
Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12
Description
Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.
Time Frame
Baseline, Week 4 and Week 12
Title
Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12
Description
Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12
Description
NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement.
Time Frame
Baseline, Week 4 and Week 12
Title
Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12
Description
Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12
Description
SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.
Time Frame
Baseline, Week 4 and Week 12
Title
Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12
Description
Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12
Description
The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
Description
PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
Description
UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12
Description
OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.
Time Frame
Baseline, Week 4 and Week 12
Title
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12
Description
ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.
Time Frame
Baseline, Week 12
Title
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Description
BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).
Time Frame
Week 12 (or Early Withdrawal)
Title
Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12
Description
TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'.
Time Frame
Week 12 (or Early Withdrawal)
Title
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Description
KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ely
State/Province
Cambridgeshire
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Crewe
State/Province
Cheshire
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Fowey
State/Province
Cornwall
ZIP/Postal Code
PL23 1DT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR18 4JH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S44 5BL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bexhill on Sea
State/Province
East Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Baillieston
State/Province
Glasgow
ZIP/Postal Code
G69 7AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY4 3AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hinckley
State/Province
Leicestershire
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
West Didsbury
State/Province
Manchester
ZIP/Postal Code
M20 2LR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ashford
State/Province
Middlesex
ZIP/Postal Code
TW15 3EA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Mortimer
State/Province
Reading
ZIP/Postal Code
RG7 2BH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ayrshire
State/Province
Scotland
ZIP/Postal Code
KA12 0AY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Falkirk
State/Province
Scotland
ZIP/Postal Code
FK1 5QE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Winterton
State/Province
Scunthorpe
ZIP/Postal Code
DN15 9TA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA1 2SR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN9 1ND
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S7 2DW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Addlestone
State/Province
Surrey
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leatherhead
State/Province
Surrey
ZIP/Postal Code
KT24 6QT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Worthing
State/Province
West Sussex
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bradford-on-Avon
State/Province
Wiltshire
ZIP/Postal Code
BA1 5DQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chippenham
State/Province
Wilts
ZIP/Postal Code
SN14 8GT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA2 4BY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bucks
ZIP/Postal Code
HP22 5LB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hertfordshire
ZIP/Postal Code
WD25 0EA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
W1P 9LL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northants
ZIP/Postal Code
NN8 4RW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swindon
ZIP/Postal Code
SN25 4YZ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221058&StudyName=UK%20Study%20Assessing%20Flexible%20Dose%20Fesoterodine%20in%20Adults%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

UK Study Assessing Flexible Dose Fesoterodine in Adults

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