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A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Fesoterodine

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring incontinence OAB urgency nocturia

Eligibility Criteria

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

Inclusion Criteria:

Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fesoterodine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours

Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12

Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

Secondary Outcome Measures

Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4

Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12

Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).

Number of Nocturnal Micturitions Per 24 Hours

Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. 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 From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12

Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12

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 (100*(Week 4 or 12 - baseline)/baseline).

Mean Number of Micturitions Per 24 Hours

Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12

Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.

Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12

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 (100*(Week 4 or 12 - baseline)/baseline).

Number of Micturition-related Urgency Episodes Per 24 Hours

The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12

Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12

Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).

Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12

Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12

Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).

Nocturnal Frequency-urgency Sum Rating Per 24 Hours

Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.

Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12

Frequency-urgency Sum Rating Per 24 Hours

Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.

Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12

Mean Voided Volume Per Nocturnal Micturition

Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.

Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12

Mean Voided Volume Per Micturition

Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.

Change From Baseline in Mean Voided Volume Per Micturition at Week 12

Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.

Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). 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)/range]*100. Higher scores values indicative of greater symptom bother.

Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12

Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)

OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12

Full Information

NCT ID

NCT00911937

First Posted

June 1, 2009

Last Updated

November 7, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00911937

Brief Title

A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Official Title

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

incontinence OAB urgency nocturia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

963 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fesoterodine

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fesoterodine

Intervention Description

Fesoterodine 4mg and 8 mg tablets taken daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo sham 4mg and 8 mg tables taken daily.

Primary Outcome Measure Information:

Title

Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours

Description

Time Frame

Baseline

Title

Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4

Description

Time Frame

Baseline and Week 4

Title

Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Number of Nocturnal Micturitions Per 24 Hours

Description

Time Frame

Baseline

Title

Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Mean Number of Micturitions Per 24 Hours

Description

Time Frame

Baseline

Title

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12

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 (100*(Week 4 or 12 - baseline)/baseline).

Time Frame

Baseline, Week 4 and 12

Title

Number of Micturition-related Urgency Episodes Per 24 Hours

Description

Time Frame

Baseline

Title

Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

Description

Time Frame

Baseline

Title

Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12

Description

Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).

Time Frame

Baseline, Week 4 and 12

Title

Nocturnal Frequency-urgency Sum Rating Per 24 Hours

Description

Time Frame

Baseline

Title

Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Frequency-urgency Sum Rating Per 24 Hours

Description

Time Frame

Baseline

Title

Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Mean Voided Volume Per Nocturnal Micturition

Description

Time Frame

Baseline

Title

Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12

Description

Time Frame

Baseline and Week 12

Title

Mean Voided Volume Per Micturition

Description

Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.

Time Frame

Baseline

Title

Change From Baseline in Mean Voided Volume Per Micturition at Week 12

Description

Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.

Time Frame

Baseline and Week 12

Title

Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

Description

Time Frame

Baseline

Title

Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)

Description

Time Frame

Baseline

Title

Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2) Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3) Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary) Exclusion Criteria: A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, 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

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Pfizer Investigational Site

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85395

Country

United States

Facility Name

Pfizer Investigational Site

City

Litchfield Park

State/Province

Arizona

ZIP/Postal Code

85340

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Pfizer Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

Pfizer Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Pfizer Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Pfizer Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Pfizer Investigational Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

Pfizer Investigational Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

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

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Pfizer Investigational Site

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Pfizer Investigational Site

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06032

Country

United States

Facility Name

Pfizer Investigational Site

City

New Britain

State/Province

Connecticut

ZIP/Postal Code

06052

Country

United States

Facility Name

Pfizer Investigational Site

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06850

Country

United States

Facility Name

Pfizer Investigational Site

City

Dover

State/Province

Delaware

ZIP/Postal Code

19904

Country

United States

Facility Name

Pfizer Investigational Site

City

Bonita Springs

State/Province

Florida

ZIP/Postal Code

34134

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34601

Country

United States

Facility Name

Pfizer Investigational Site

City

DeFuniak Springs

State/Province

Florida

ZIP/Postal Code

32435

Country

United States

Facility Name

Pfizer Investigational Site

City

Destin

State/Province

Florida

ZIP/Postal Code

32541

Country

United States

Facility Name

Pfizer Investigational Site

City

Leesburg

State/Province

Florida

ZIP/Postal Code

34748

Country

United States

Facility Name

Pfizer Investigational Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Pfizer Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Pfizer Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Pfizer Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

Pfizer Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Pfizer Investigational Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329-5102

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

Chicago

State/Province

Illinois

ZIP/Postal Code

60634

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60654

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46825

Country

United States

Facility Name

Pfizer Investigational Site

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

Facility Name

Pfizer Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

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

Overland Park

State/Province

Kansas

ZIP/Postal Code

66202

Country

United States

Facility Name

Pfizer Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Pfizer Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Pfizer Investigational Site

City

Pratt

State/Province

Kansas

ZIP/Postal Code

67124

Country

United States

Facility Name

Pfizer Investigational Site

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

Pfizer Investigational Site

City

Mount Sterling

State/Province

Kentucky

ZIP/Postal Code

40353

Country

United States

Facility Name

Pfizer Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71106

Country

United States

Facility Name

Pfizer Investigational Site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

Pfizer Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Pfizer Investigational Site

City

Hyannis

State/Province

Massachusetts

ZIP/Postal Code

02601

Country

United States

Facility Name

Pfizer Investigational Site

City

Milford

State/Province

Massachusetts

ZIP/Postal Code

01757

Country

United States

Facility Name

Pfizer Investigational Site

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02740

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

Troy

State/Province

Michigan

ZIP/Postal Code

48098

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

Olive Branch

State/Province

Mississippi

ZIP/Postal Code

38654

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Pfizer Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Pfizer Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Pfizer Investigational Site

City

Hamilton

State/Province

New Jersey

ZIP/Postal Code

08690

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

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

Kingston

State/Province

New York

ZIP/Postal Code

12401

Country

United States

Facility Name

Pfizer Investigational Site

City

Manlius

State/Province

New York

ZIP/Postal Code

13104

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Pfizer Investigational Site

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

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

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

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

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Pfizer Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Pfizer Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

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

Westerville

State/Province

Ohio

ZIP/Postal Code

43081

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Pfizer Investigational Site

City

Bala-Cynwyd

State/Province

Pennsylvania

ZIP/Postal Code

19004

Country

United States

Facility Name

Pfizer Investigational Site

City

Bridgeville

State/Province

Pennsylvania

ZIP/Postal Code

15017

Country

United States

Facility Name

Pfizer Investigational Site

City

Lansdale

State/Province

Pennsylvania

ZIP/Postal Code

19446

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

Country

United States

Facility Name

Pfizer Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

Pfizer Investigational Site

City

Sellersville

State/Province

Pennsylvania

ZIP/Postal Code

18960

Country

United States

Facility Name

Pfizer Investigational Site

City

East Greenwich

State/Province

Rhode Island

ZIP/Postal Code

02818

Country

United States

Facility Name

Pfizer Investigational Site

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

Facility Name

Pfizer Investigational Site

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Pfizer Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Pfizer Investigational Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Pfizer Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

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

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

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

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Pfizer Investigational Site

City

New Tazewell

State/Province

Tennessee

ZIP/Postal Code

37825

Country

United States

Facility Name

Pfizer Investigational Site

City

Bryan

State/Province

Texas

ZIP/Postal Code

77802

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

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

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

Pfizer Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Pfizer Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Pfizer Investigational Site

City

Mountlake Terrace

State/Province

Washington

ZIP/Postal Code

98043

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

Spokane

State/Province

Washington

ZIP/Postal Code

99207

Country

United States

Facility Name

Pfizer Investigational Site

City

Menomonee Falls

State/Province

Wisconsin

ZIP/Postal Code

53051

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221048

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

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A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Overactive Bladder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial