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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tolterodine ER

Placebo

Fesoterodine

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Treatment of overactive bladder

Eligibility Criteria

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

Inclusion Criteria:

Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

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).

Secondary Outcome Measures

Change From Baseline in Mean Voided Volume Per Micturition

Mean voided volume in milliliters (mL) 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 total number of micturitions divided by the total number of diary days collected at that visit.

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 1 or 4 or 12 - 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 total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant 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 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.

Change From Baseline in Mean Number of Urgency Urinary Incontinence (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).

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 Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 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).

Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). 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 Number of Severe Urgency Episodes Per 24 Hours

Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 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).

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours

Percent change calculated as change in severe urgency episodes (USS rating ≥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 Urinary Sensation Scale (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 total number of micturitions per 24 hours with non-missing rating 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 From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)

Frequency-Urgency Sum 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).

Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary

Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on 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 Patient Perception of Bladder Condition (PPBC)

Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), 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 Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.

Number of participants 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

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. Negative change in Symptom Bother Score indicates improvement.

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12

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] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.

Full Information

NCT ID

NCT00611026

First Posted

January 28, 2008

Last Updated

January 28, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00611026

Brief Title

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

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

Keywords

Treatment of overactive bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

2417 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Tolterodine ER

Intervention Description

The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo treatment will be once daily(QD) for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Fesoterodine

Intervention Description

The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 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

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Mean Voided Volume Per Micturition

Description

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 total number of micturitions divided by the total number of diary days collected at that visit.

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Percent Change From Baseline of Micturitions Per 24 Hours

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4

Description

Time Frame

Baseline, Week 1, Week 4

Title

Percent Change From Baseline of UUI Episodes Per 24 Hours

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)

Description

Time Frame

Baseline, Week 1, Week 4, Week 12

Title

Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary

Description

Time Frame

Week 1, Week 4, Week 12

Title

Change From Baseline in Patient Perception of Bladder Condition (PPBC)

Description

Time Frame

Baseline, Week 1, Week, 4, Week 12

Title

Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.

Description

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

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12

Description

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit. Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit. Exclusion Criteria: Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon. Subjects with clinically significant hepatic or renal disease or other significant unstable diseases. OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc. Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

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

Enterprise

State/Province

Alabama

ZIP/Postal Code

36330

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

Montgomery

State/Province

Alabama

ZIP/Postal Code

36117

Country

United States

Facility Name

Pfizer Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85225

Country

United States

Facility Name

Pfizer Investigational Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

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

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Pfizer Investigational Site

City

Clovis

State/Province

California

ZIP/Postal Code

93611

Country

United States

Facility Name

Pfizer Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93710

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

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pfizer Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Pfizer Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Pfizer Investigational Site

City

Vista

State/Province

California

ZIP/Postal Code

92083

Country

United States

Facility Name

Pfizer Investigational Site

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

Pfizer Investigational Site

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Pfizer Investigational Site

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

Pfizer Investigational Site

City

Bonita Spring

State/Province

Florida

ZIP/Postal Code

34134

Country

United States

Facility Name

Pfizer Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Pfizer Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Pfizer Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

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

Longwood

State/Province

Florida

ZIP/Postal Code

32779

Country

United States

Facility Name

Pfizer Investigational Site

City

Loxahatchee

State/Province

Florida

ZIP/Postal Code

33470

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

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

Naples

State/Province

Florida

ZIP/Postal Code

34102

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

Stuart

State/Province

Florida

ZIP/Postal Code

34996

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

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

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

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

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

Peoria

State/Province

Illinois

ZIP/Postal Code

61614

Country

United States

Facility Name

Pfizer Investigational Site

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Pfizer Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Pfizer Investigational Site

City

Noblesville

State/Province

Indiana

ZIP/Postal Code

46158

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

66215

Country

United States

Facility Name

Pfizer Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Pfizer Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

Pfizer Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Pfizer Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

Pfizer Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70002

Country

United States

Facility Name

Pfizer Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21211

Country

United States

Facility Name

Pfizer Investigational Site

City

Bel Air

State/Province

Maryland

ZIP/Postal Code

21014

Country

United States

Facility Name

Pfizer Investigational Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Pfizer Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48103

Country

United States

Facility Name

Pfizer Investigational Site

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

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

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Pfizer Investigational Site

City

Sartell

State/Province

Minnesota

ZIP/Postal Code

56377

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

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

Pfizer Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Pfizer Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

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

68134

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

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

Williamsville

State/Province

New York

ZIP/Postal Code

14221

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

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Pfizer Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45212

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

Bensalem

State/Province

Pennsylvania

ZIP/Postal Code

19020

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

15243

Country

United States

Facility Name

Pfizer Investigational Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

Pfizer Investigational Site

City

Cumberland

State/Province

Rhode Island

ZIP/Postal Code

02864

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

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Pfizer Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Pfizer Investigational Site

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Pfizer Investigational Site

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

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Tennessee

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Plovdiv

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Sofia

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Surrey

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Winnipeg

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Chicoutimi

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Montreal

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Montreal

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Montreal

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Bogota

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Tallinn

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Estonia

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Tallinn

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Estonia

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Tartu

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51014

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Estonia

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Berlin

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10629

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Germany

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Berlin

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10787

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Gruenstadt

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67269

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Hamburg

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20253

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Krumbach

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86381

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Leipzig

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04103

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Marburg

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35039

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Muelheim a.d. Ruhr

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45468

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Muenchen

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81241

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Muenchen

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81925

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Germany

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Heraklion/Voutes

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Crete

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71001

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Greece

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Alexandroupolis

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Athens, Maroussi

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14126

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Greece

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Larisa

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41110

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Greece

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Thessaloniki

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546 35

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3100

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Hungary

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Szentes

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Hyderabad

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Gujarat

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India

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Karnataka

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560 010

Country

India

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Pfizer Investigational Site

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Pune

State/Province

Maharashtra

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411 053

Country

India

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New Delhi

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110001

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India

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Chonbuk

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134-791

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Riga

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LV 1002

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Latvia

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49476

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50425

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01118

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10207

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50586

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59100

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15-276

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Poland

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Bydgoszcz

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85-094

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Poland

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Gdynia

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81-366

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Poland

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Krakow

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30-017

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Lublin

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20-954

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Poland

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Poznan

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61-251

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Slupsk

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76-200

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Poland

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Bucuresti

State/Province

Sector 5,

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050653

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Romania

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Arad

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310175

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Romania

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Bucuresti

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041345

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Romania

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Sibiu

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550245

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Romania

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Moscow

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101000

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Moscow

ZIP/Postal Code

105425

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Russian Federation

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City

Moscow

ZIP/Postal Code

109388

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Russian Federation

Facility Name

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City

Moscow

ZIP/Postal Code

115516

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Russian Federation

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City

Moscow

ZIP/Postal Code

117997

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Russian Federation

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City

Moscow

ZIP/Postal Code

119991

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Russian Federation

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Rostov-on-Don

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344022

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Russian Federation

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City

Saint-Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

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Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

190013

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

229899

Country

Singapore

Facility Name

Pfizer Investigational Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

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Pfizer Investigational Site

City

Povazska Bystrica

ZIP/Postal Code

017 01

Country

Slovakia

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City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Trencin

ZIP/Postal Code

911 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Zvolen

ZIP/Postal Code

960 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Claremont

State/Province

Cape Town

ZIP/Postal Code

8001

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

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

Durban

State/Province

Kwa Zulu Natal

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

Pretoria

ZIP/Postal Code

0083

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Roodepoort

ZIP/Postal Code

1715

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Pfizer Investigational Site

City

La Laguna

State/Province

Santa Cruz de Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Pfizer Investigational Site

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35010

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Pfizer Investigational Site

City

Karlskoga

ZIP/Postal Code

691 81

Country

Sweden

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Pfizer Investigational Site

City

Malmo

ZIP/Postal Code

211 52

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Norrkoping

ZIP/Postal Code

601 82

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Orebro

ZIP/Postal Code

701 46

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Skovde

ZIP/Postal Code

541 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Stockholm

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Chernivtsi

ZIP/Postal Code

58002

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Kyiv

ZIP/Postal Code

04053

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Uzhorod

ZIP/Postal Code

88000

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

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221046&StudyName=Clinical%20Trial%20to%20Evaluate%20the%20Efficacy%20and%20Safety%20of%20Fesoterodine%20in%20Comparison%20to%20Tolterodine%20ER%20in%20Patients%20with%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 Extended Release(ER)in Patients With Overactive Bladder.

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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Overactive Bladder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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