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A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder. (SOFIA)

Primary Purpose

Urinary Bladder, Overactive

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Placebo

Fesoterodine fumarate

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Overactive bladder syndrome, fesoterodine, elderly, flexible dose regimen, urgency, frequency, urge urinary incontinence, anticholinergic, antimuscarinic

Eligibility Criteria

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

Inclusion Criteria:

Male or female ≥65 years old.
Overactive bladder symptoms for at least 3 months prior to study start.
Eight or more micturitions per 24 hours as confirmed by diary records

Exclusion Criteria:

Predominant Stress Urinary Incontinence
Active or recurrent bladder infections
Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Placebo

Fesoterodine

Arm Description

Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated.

Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after 4 weeks if clinically indicated. Subsequently the dose can be reduced to 4mg if clinically indicated.

Outcomes

Primary Outcome Measures

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

Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 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 = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.

Secondary Outcome Measures

Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of >=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.

Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.

Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

Severe micturition-related urgency episodes defined as those with USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12

Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.

Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12

Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.

Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12

Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.

Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12

Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and 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. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.

Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12

UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.

Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12

UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.

Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12

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 = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.

Percentage of Participants Who Were Incontinent at Baseline and Became Dry

Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.

Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12

Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.

Percentage of Participants With Improvement at Week 12

Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: "My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment." Improvement was defined as a rating of 1 or 2.

Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4

PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).

Change From Baseline in PPBC at Week 8

Change From Baseline in PPBC at Week 12

Change From Baseline in PPBC at Week 24

Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4

PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.

Change From Baseline in PPUS at Week 8

Change From Baseline in PPUS at Week 12

Change From Baseline in PPUS at Week 24

Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24

OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.

Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24

OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.

Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24

OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.

Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24

OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.

Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24

OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.

Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12

KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.

Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12

EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.

Change From Baseline in EQ-5D- Each Dimension Score at Week 12

EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.

Change From Baseline in Mini Mental State Examination (MMSE) at Week 12

MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.

Full Information

NCT ID

NCT00798434

First Posted

November 25, 2008

Last Updated

November 8, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00798434

Brief Title

A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.

Acronym

SOFIA

Official Title

A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (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

The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.

6. Conditions and Keywords

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

Urinary Bladder, Overactive

Keywords

Overactive bladder syndrome, fesoterodine, elderly, flexible dose regimen, urgency, frequency, urge urinary incontinence, anticholinergic, antimuscarinic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

794 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Active Comparator

Arm Description

Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated.

Arm Title

Fesoterodine

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo administered orally in the morning or evening.

Intervention Type

Drug

Intervention Name(s)

Fesoterodine fumarate

Other Intervention Name(s)

Toviaz

Intervention Description

Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

Description

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

Description

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

Description

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12

Description

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12

Description

Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12

Description

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12

Description

Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and 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. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12

Description

UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12

Description

UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12

Description

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Percentage of Participants Who Were Incontinent at Baseline and Became Dry

Description

Time Frame

Weeks 8 to 12

Title

Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12

Description

Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.

Time Frame

Baseline and Weeks 4, 8, and 12

Title

Percentage of Participants With Improvement at Week 12

Description

Time Frame

Week 12

Title

Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline in PPBC at Week 8

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline in PPBC at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in PPBC at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4

Description

Time Frame

Baseline and Weeks 4

Title

Change From Baseline in PPUS at Week 8

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline in PPUS at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in PPUS at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 24

Title

Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24

Description

OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.

Time Frame

Baseline and Weeks 4, 8, 12, and 24

Title

Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 24

Title

Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24

Description

Time Frame

Weeks 12 and 24

Title

Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24

Description

Time Frame

Weeks 12 and 24

Title

Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in EQ-5D- Each Dimension Score at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Mini Mental State Examination (MMSE) at Week 12

Description

Time Frame

Baseline and Week 12

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Improvement at Week 24

Description

Time Frame

Pre-baseline and Week 24

Title

Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24

Description

Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of >=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24

Description

Time Frame

Baseline and Week 24

Title

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

Description

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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.

Time Frame

Baseline and Week 24

Title

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

Description

Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24

Description

UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥65 years old. Overactive bladder symptoms for at least 3 months prior to study start. Eight or more micturitions per 24 hours as confirmed by diary records Exclusion Criteria: Predominant Stress Urinary Incontinence Active or recurrent bladder infections Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.

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

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Pfizer Investigational Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Edegem

ZIP/Postal Code

B-2650

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

B-9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kouvola

ZIP/Postal Code

45200

Country

Finland

Facility Name

Pfizer Investigational Site

City

OYS

ZIP/Postal Code

90029

Country

Finland

Facility Name

Pfizer Investigational Site

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

Pfizer Investigational Site

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10249

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

14052

Country

Germany

Facility Name

Pfizer Investigational Site

City

Frankfurt

ZIP/Postal Code

60435

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

81927

Country

Germany

Facility Name

Pfizer Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Pfizer Investigational Site

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Pfizer Investigational Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Pfizer Investigational Site

City

Foggia

ZIP/Postal Code

71100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Terracina, LT

ZIP/Postal Code

04019

Country

Italy

Facility Name

Pfizer Investigational Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Pfizer Investigational Site

City

Oslo

ZIP/Postal Code

NO-0257

Country

Norway

Facility Name

Pfizer Investigational Site

City

Tonsberg

ZIP/Postal Code

3103

Country

Norway

Facility Name

Pfizer Investigational Site

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Pfizer Investigational Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Lisboa

ZIP/Postal Code

1990-273

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Porto

ZIP/Postal Code

4050-011

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Porto

ZIP/Postal Code

4099-005

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

851 05

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Galanta

ZIP/Postal Code

924 22

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Kosice - Saca

ZIP/Postal Code

040 15

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Kosice

ZIP/Postal Code

040 11

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Martorell

State/Province

Barcelona

ZIP/Postal Code

08760

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Pfizer Investigational Site

City

Getafe

State/Province

Madrid

ZIP/Postal Code

28905

Country

Spain

Facility Name

Pfizer Investigational Site

City

Manacor

State/Province

Palma de Mallorca

ZIP/Postal Code

07500

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Eslov

ZIP/Postal Code

241 23

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Goteborg

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Malmo

ZIP/Postal Code

211 20

Country

Sweden

Facility Name

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

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Frauenfeld

ZIP/Postal Code

CH-8501

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Samsun

ZIP/Postal Code

55200

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Bexhill on Sea

State/Province

East Sussex

ZIP/Postal Code

TN39 4SP

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Leytonstone

State/Province

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Harrow

State/Province

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

High Heaton

State/Province

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Birmingham

ZIP/Postal Code

B17 0AA

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

WC1E 6AU

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23460503

Citation

Wagg A, Khullar V, Michel MC, Oelke M, Darekar A, Bitoun CE. Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: open-label extension of the SOFIA trial. Neurourol Urodyn. 2014 Jan;33(1):106-14. doi: 10.1002/nau.22383. Epub 2013 Mar 4.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221045&StudyName=A%20study%20to%20compare%20the%20effectiveness%20and%20safety%20of%20fesoterodine%20and%20placebo%20in%20an%20elderly%20population%20of%20patients%20who%20go%20to%20the%20toi

Description

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Learn more about this trial

A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.

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A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder. (SOFIA)

Urinary Bladder, Overactive

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