Fesoterodine Flexible Dose Study

A Phase 3 study testing Fesoterodine in people with Overactive Bladder, run by Pfizer at 95 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: Fesoterodine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 896 participants
Where: 95 sitesUnited States
Study dates: Aug 2007to Mar 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Overactive bladder symptoms for greater than or equal to 3 months.
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Who cannot join

Contraindication to fesoterodine (antimuscarinics).
Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Trial locations and contacts

95 sites in 1 country.

City, postcode or hospital

95 sites in 1 country

United States95 sites

Pfizer Investigational Site
Ann Arbor, Michigan, 48103
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Bel Air, Maryland, 21014
Pfizer Investigational Site
Bethany, Oklahoma, 73008
Pfizer Investigational Site
Bonita Springs, Florida, 34134
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Cary, North Carolina, 27518
Pfizer Investigational Site
Chandler, Arizona, 85225
Pfizer Investigational Site
Charlotte, North Carolina, 28204
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cincinnati, Ohio, 45212
Pfizer Investigational Site
Cincinnati, Ohio, 45249
Pfizer Investigational Site
Corpus Christi, Texas, 78414
Pfizer Investigational Site
Cranston, Rhode Island, 02920
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Denver, Colorado, 80210
Pfizer Investigational Site
Denver, Colorado, 80211
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Englewood, Colorado, 80112
Pfizer Investigational Site
Evansville, Indiana, 47713
Pfizer Investigational Site
Garden City, New York, 11530
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Houston, Texas, 77079
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Jeffersonville, Indiana, 47130
Pfizer Investigational Site
Johnson City, Tennessee, 36701
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Kingston, New York, 12401
Pfizer Investigational Site
Lake Worth, Florida, 33461
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446
Pfizer Investigational Site
Las Vegas, Nevada, 89104
Pfizer Investigational Site
Las Vegas, Nevada, 89130
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Nebraska, 68506
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Longview, Texas, 75605
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Louisville, Kentucky, 40291
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Manlius, New York, 13104
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Mountlake Terrace, Washington, 98043
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Britain, Connecticut, 06052
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Tazewell, Tennessee, 37825
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Newburgh, Indiana, 47630
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Norman, Oklahoma, 73071
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Paw Paw, Michigan, 49079
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19115
Pfizer Investigational Site
Picayune, Mississippi, 39466
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Poughkeepsie, New York, 12601
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Rancho Cordova, California, 95670
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rochester, New York, 14609
Pfizer Investigational Site
Royal Oak, Michigan, 48073
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
Springfield, Massachusetts, 01103
Pfizer Investigational Site
St Louis, Missouri, 63117
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
State College, Pennsylvania, 16801
Pfizer Investigational Site
Stuart, Florida, 34996
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Tallahassee, Florida, 32308
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Tucson, Arizona, 85741
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
West Yarmouth, Massachusetts, 02673
Pfizer Investigational Site
Williamsville, New York, 14221
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.

Conditions: Overactive Bladder
Being tested: Fesoterodine, Placebo
Keywords: Overactive Bladder
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FesoterodineDrug
4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
PlaceboDrug
Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Study groups in NCT00536484
Study group	Role	What they receive
Fesoterodine (Double-Blind)	Experimental	Not described Receives: Drug: Fesoterodine
Placebo (Double-Blind)	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.
Change: mean at Week 12 minus mean at Baseline
Measured: Baseline and Week 12

Secondary outcomes (12)

Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.
Change: mean at observation minus mean at baseline
Measured: Baseline, Week 2 and Week 6
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.
Measured: Baseline, Week 2, Week 6 and Week 12
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.
Measured: Baseline, Week 2, Week 6 and Week 12
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine
Measured: Baseline, Week 2, Week 6 and Week 12
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.
Measured: Baseline, Week 2, Week 6 and Week 12
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit
Measured: Baseline, Week 2, Week 6 and Week 12
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
Change in frequency urgency sum is total urinary sensation scale (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. Numerical decrease indicates improvement
Measured: Baseline, Week 2, Week 6 and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement.
Change: mean at Week 12 minus mean at baseline
Measured: Baseline and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement.
Change: mean at Week 12 minus mean at baseline.
Measured: Baseline and Week 12
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline
Measured: Baseline, Week 2, Week 6 and Week 12
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet [without leaking]"). Improvement: positive score change; No change: score change=0; Deterioration: negative score change
Measured: Baseline, Week 2, Week 6 and Week 12
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement.
Change: mean at observation minus mean at baseline.
Measured: Baseline, Week 2, Week 6 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Mar 2008

First posted27 Sep 2007 (estimated)
Study startAug 2007
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Overactive BladderStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 896 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00536484
Sponsor's protocol ID: A0221014
Status last verified: Sep 2009
First submitted: 25 Sep 2007
Last updated: 15 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
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RecruitingObservational study
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Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.
ClinicalTrials.gov ID: NCT00536484
Acronym / sponsor ID: A0221014
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 896 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 27 Sep 2007 (estimated)
Results: Posted 11 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Fesoterodine (Double-Blind)	Experimental	Drug: Fesoterodine
Placebo (Double-Blind)	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Overactive bladder symptoms for greater than or equal to 3 months.
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Key exclusion criteria (4 listed)

Contraindication to fesoterodine (antimuscarinics).
Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fesoterodine4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.	Drug	Fesoterodine (Double-Blind)
PlaceboMatched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.	Drug	Placebo (Double-Blind)

Primary outcome

Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
Time frame: Baseline and Week 12
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline

12 secondary outcomes

Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline
Time frame: Baseline, Week 2 and Week 6
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale
Time frame: Baseline and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
Time frame: Baseline and Week 12
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
Time frame: Baseline, Week 2, Week 6 and Week 12

Results and safety

Results posted to the registry on 11 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	445	385
Fesoterodine	438	382

Primary outcome: Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: number of episodes per 24 hours

Measure	Placebo n = 434	Fesoterodine n = 428
Value	-2.1 (0.1)	-2.9 (0.1)

Placebo vs Fesoterodine: Mean Difference (Final Values): -0.7 (95% CI -1.1 to -0.4), p = 0.0002, ANCOVA

Population analysed: Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward \[LOCF)). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of ?	130 of ?	Not reported
Fesoterodine	5 of ?	199 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Overactive Bladder

Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

95 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fesoterodine in people with Overactive Bladder, run by Pfizer at 95 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00536484, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009; AzTrials last refreshed its copy on 29 Oct 2026.