Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fesoterodine fumarate
placebo
tolterodine tartrate
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day
Exclusion Criteria:
- Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
- 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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Fesoterodine
Placebo
Tolterodine
Arm Description
Tablets
Tablets and capsules
Capsules
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.
Secondary Outcome Measures
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Percent Change From Baseline of UUI Episodes Per 24 Hours.
UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Change From Baseline in Mean Voided Volume Per Micturition.
Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Change From Baseline in Mean Number of Micturitions Per 24 Hours.
The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.
Percent Change From Baseline of Micturitions Per 24 Hours.
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.
Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.
Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Percent Change From Baseline of Urgency Episodes Per 24 Hours.
Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.
Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.
Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.
Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Change From Baseline in Patient Perception of Bladder Condition (PPBC).
Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00444925
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
Official Title
12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1712 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fesoterodine
Arm Type
Experimental
Arm Description
Tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tablets and capsules
Arm Title
Tolterodine
Arm Type
Active Comparator
Arm Description
Capsules
Intervention Type
Drug
Intervention Name(s)
fesoterodine fumarate
Intervention Description
4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
once daily (OD)for 12 weeks
Intervention Type
Drug
Intervention Name(s)
tolterodine tartrate
Intervention Description
4 mg once daily (OD) for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Description
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Description
UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame
Baseline, Week 1, Week 4
Title
Percent Change From Baseline of UUI Episodes Per 24 Hours.
Description
UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Mean Voided Volume Per Micturition.
Description
Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours.
Description
The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Percent Change From Baseline of Micturitions Per 24 Hours.
Description
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.
Description
Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.
Description
Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
Description
Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Percent Change From Baseline of Urgency Episodes Per 24 Hours.
Description
Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.
Description
Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.
Description
Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.
Description
Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
Description
Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Patient Perception of Bladder Condition (PPBC).
Description
Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Time Frame
Baseline, Week 1, Week, 4, Week 12
Title
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
Description
Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Time Frame
Baseline, Week 1, Week 4, Week 12
Title
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
Description
Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
Description
HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day
Exclusion Criteria:
Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
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
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pfizer Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Pfizer Investigational Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Pfizer Investigational Site
City
Orangevale
State/Province
California
ZIP/Postal Code
95662
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-6204
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Pfizer Investigational Site
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Coeur D Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Pfizer Investigational Site
City
Sandpoint
State/Province
Idaho
ZIP/Postal Code
83864
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Pfizer Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Pfizer Investigational Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Pfizer Investigational Site
City
Shrevport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Pfizer Investigational Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Pfizer Investigational Site
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Pfizer Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Pfizer Investigational Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Pfizer Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Pfizer Investigational Site
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Pfizer Investigational Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Pfizer Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Pfizer Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18106
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3180
Country
United States
Facility Name
Pfizer Investigational Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Pfizer Investigational Site
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Pfizer Investigational Site
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Pfizer Investigational Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pfizer Investigational Site
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
Pfizer Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Tessenderlo
ZIP/Postal Code
3980
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Salvador
State/Province
BA
ZIP/Postal Code
40420-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
CEP 20551-030
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Campinas
State/Province
SP
ZIP/Postal Code
13084-882
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04262-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4R6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3J8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3S 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Rancagua
State/Province
VI Región
ZIP/Postal Code
2820945
Country
Chile
Facility Name
Pfizer Investigational Site
City
Puerto Montt
ZIP/Postal Code
5480000
Country
Chile
Facility Name
Pfizer Investigational Site
City
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Alajuela
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Cartago
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Jablonec nad Nisou
ZIP/Postal Code
466 60
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 38
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 8
ZIP/Postal Code
180 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Nykoebing Falster
ZIP/Postal Code
4800
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Ahaus
ZIP/Postal Code
41683
Country
Germany
Facility Name
Pfizer Investigational Site
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Pfizer Investigational Site
City
Karlsruhe
ZIP/Postal Code
76199
Country
Germany
Facility Name
Pfizer Investigational Site
City
Krumbach
ZIP/Postal Code
86381
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Facility Name
Pfizer Investigational Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muelheim a.d. Ruhr
ZIP/Postal Code
45468
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81241
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Pfizer Investigational Site
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
State/Province
Attiki
ZIP/Postal Code
10552
Country
Greece
Facility Name
Pfizer Investigational Site
City
Ioannina
State/Province
Ipiros
ZIP/Postal Code
45001
Country
Greece
Facility Name
Pfizer Investigational Site
City
Rio, Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Pfizer Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4026
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 001
Country
India
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 082
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302 004
Country
India
Facility Name
Pfizer Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632 004
Country
India
Facility Name
Pfizer Investigational Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Pfizer Investigational Site
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
100-380
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Bergen
ZIP/Postal Code
5005
Country
Norway
Facility Name
Pfizer Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Pfizer Investigational Site
City
Lysaker
ZIP/Postal Code
1366
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0264
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
NO-0257
Country
Norway
Facility Name
Pfizer Investigational Site
City
Sandnes
ZIP/Postal Code
4313
Country
Norway
Facility Name
Pfizer Investigational Site
City
Surco
State/Province
Lima
ZIP/Postal Code
L33
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Bialystok
ZIP/Postal Code
15-950
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
91-463
Country
Poland
Facility Name
Pfizer Investigational Site
City
Szczecin
ZIP/Postal Code
70-11
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Pfizer Investigational Site
City
Arad
ZIP/Postal Code
310175
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
041345
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
050653
Country
Romania
Facility Name
Pfizer Investigational Site
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Pfizer Investigational Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Pfizer Investigational Site
City
Moscow
State/Province
Russia
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Russia
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
117815
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown
State/Province
Gauteng Province
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Vosloorus
State/Province
Gauteng
ZIP/Postal Code
1475
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pietermaritzburg
State/Province
Kwa Zulu Natal
ZIP/Postal Code
3201
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Pfizer Investigational Site
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Huskvarna
ZIP/Postal Code
561 36
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lulea
ZIP/Postal Code
97180
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Skovde
ZIP/Postal Code
541 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Frauenfeld
ZIP/Postal Code
CH-8500
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Luzern 16
ZIP/Postal Code
CH-6000
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Niao-Sung Hsiang
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65000
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Zaporizhzhia
ZIP/Postal Code
69000
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
35881009
Citation
Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
Results Reference
derived
PubMed Identifier
21428726
Citation
Corcos J, Angulo JC, Garely AD, Carlsson M, Gong J, Guan Z; Fesoterodine Assessment and Comparison Versus Tolterodine (FACT) Study Group. Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. Curr Med Res Opin. 2011 May;27(5):1059-65. doi: 10.1185/03007995.2011.565044. Epub 2011 Mar 23.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221008&StudyName=Clinical%20Trial%20to%20Evaluate%20the%20Efficacy%20and%20Safety%20of%20Fesoterodine%20in%20Comparison%20to%20Tolterodine%20for%20Overactive%20Bladder
Description
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Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
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