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Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fesoterodine fumarate
Placebo
fesoterodine fumarate
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

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

Inclusion Criteria:

  • Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.

Exclusion Criteria:

  • Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
  • Patient has a known neurological disease influencing bladder function.
  • Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.

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
  • 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 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Fesoterodine fumarate 4 mg (Double-Blind)

Placebo (Double-Blind)

Fesoterodine fumarate 8 mg (Double-Blind)

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.

Secondary Outcome Measures

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline.
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline.
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline.
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline.
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline.
Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems Change: mean at Week 12 minus mean at Baseline.
The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems

Full Information

First Posted
November 19, 2007
Last Updated
July 11, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00561951
Brief Title
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Official Title
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

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 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
951 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fesoterodine fumarate 4 mg (Double-Blind)
Arm Type
Experimental
Arm Title
Placebo (Double-Blind)
Arm Type
Placebo Comparator
Arm Title
Fesoterodine fumarate 8 mg (Double-Blind)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fesoterodine fumarate
Intervention Description
8mg tablets OD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Corresponding placebo tablets OD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
fesoterodine fumarate
Intervention Description
4mg tablets 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.
Description
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description
Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Time Frame
Baseline to Weeks 2, 4, 8, and 12
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Description
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Description
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame
Baseline to Weeks 2, 4, 8, and 12
Title
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
Description
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Time Frame
Baseline to Weeks 2, 4, 8, and 12
Title
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
Description
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline.
Time Frame
Baseline to Weeks 2, 4, 8, and 12
Title
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
Description
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Description
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame
Baseline to Weeks 2, 4, 8, and 12
Title
Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
Description
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Description
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame
Baseline to Weeks 2, 4, 8, and 12
Title
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Description
King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week12
Title
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description
The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Title
Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
Description
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems Change: mean at Week 12 minus mean at Baseline.
Time Frame
Baseline to Week 12
Title
The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.
Description
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day. Exclusion Criteria: Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients. Patient has a known neurological disease influencing bladder function. Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
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
Kowloon
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuo-ku, Chiba-shi
State/Province
Chiba-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Eiheiji-cyo,yoshida-gun,
State/Province
Fukui-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka-Shi
State/Province
Fukuoka-Ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koga-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minami-ku, Fukuoka-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishi-ku
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sawara-ku
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Amagasaki-shi
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suma-ku, Kobe-shi
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Higashinada
State/Province
Hyougo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nada-ku, Kobe-shi
State/Province
Hyougo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takaraduka-city
State/Province
Hyougo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Aira-gun, Aira-chou,
State/Province
Kagosima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawasakishi
State/Province
Kanagawaken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Isogo-ku, Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sagamihara-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tama-ku, Kawasaki-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kouchi-shi
State/Province
Kouchi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tamana-shi
State/Province
Kumamoto-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Matumoto-Shi
State/Province
Nagano-Ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Matsumoto-shi
State/Province
Nagano
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hunaki-cho, Ibaraki-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kita-ku, Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kosobe-cho, Takatsuki-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minami-ku, Sakai-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishinari-ku
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suita-shi,
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suita-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toyonaka-city
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yodogawa-Ku
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama-shi
State/Province
Saitama-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Satte-shi
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Wakou-shi
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Gotenbashi
State/Province
Shizuokaken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Susono
State/Province
Shizuokaken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chofu-shi
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fucyushi
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishitokyo-shi
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setgaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suginami-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sumida-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuou-shi
State/Province
Yamanashi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumamoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Cheonan-si
State/Province
Chungcheongnam-do
ZIP/Postal Code
330-715
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Pusan
ZIP/Postal Code
602-739
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
136-705
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Chiayi Country
ZIP/Postal Code
613
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Koahsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221005&StudyName=Dose-Finding%20Study%20To%20Evaluate%20The%20Efficacy%2C%20Tolerability%20And%20Safety%20Of%20Fesoterodine%20In%20Comparison%20To%20Placebo%20For%20Overactive%20Bladder.
Description
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Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

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