MedDataX Logo

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

NCT ID: NCT00561951

Last Updated: 2011-07-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

951 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

NCT00658684

Overactive Bladder
COMPLETED PHASE3

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

NCT00911937

Overactive Bladder
COMPLETED PHASE4

Fesoterodine Flexible Dose Study

NCT00536484

Overactive Bladder
COMPLETED PHASE3

Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years

NCT00857896

Overactive Bladder Neurogenic Detrusor Overactivity
COMPLETED PHASE2

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.

NCT00798434

Urinary Bladder, Overactive
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fesoterodine fumarate 4 mg (Double-Blind)

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

4mg tablets OD for 12 weeks

Placebo (Double-Blind)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Corresponding placebo tablets OD for 12 weeks

Fesoterodine fumarate 8 mg (Double-Blind)

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

8mg tablets OD for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fesoterodine fumarate

8mg tablets OD for 12 weeks

Intervention Type DRUG

Placebo

Corresponding placebo tablets OD for 12 weeks

Intervention Type DRUG

fesoterodine fumarate

4mg tablets OD for 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer Inc

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Kowloon, , Hong Kong

Site Status

Pfizer Investigational Site

Shatin, , Hong Kong

Site Status

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Chuo-ku, Chiba-shi, Chiba, Japan

Site Status

Pfizer Investigational Site

Eiheiji-cyo,yoshida-gun,, Fukui, Japan

Site Status

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Koga-shi, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Minami-ku, Fukuoka-shi, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Nishiku, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Sawara-ku, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Amagasaki-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Higashinada, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Nada-ku, Kobe-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Suma-ku, Kobe-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Takaraduka-city, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Aira-gun, Aira-chou,, Kagoshima-ken, Japan

Site Status

Pfizer Investigational Site

Isogo-ku, Yokohama-shi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Kawasakishi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Sagamihara-shi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Tama-ku, Kawasaki-shi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Kochi, Kochi, Japan

Site Status

Pfizer Investigational Site

Kumamoto, Kumamoto, Japan

Site Status

Pfizer Investigational Site

Tamana-shi, Kumamoto, Japan

Site Status

Pfizer Investigational Site

Matsumoto-shi, Nagano, Japan

Site Status

Pfizer Investigational Site

Matumoto-Shi, Nagano, Japan

Site Status

Pfizer Investigational Site

Hunaki-cho, Ibaraki-shi, Osaka, Japan

Site Status

Pfizer Investigational Site

Kita-ku, Osaka-shi, Osaka, Japan

Site Status

Pfizer Investigational Site

Kosobe-cho, Takatsuki-shi, Osaka, Japan

Site Status

Pfizer Investigational Site

Minami-ku, Sakai-shi, Osaka, Japan

Site Status

Pfizer Investigational Site

Nishinari-ku, Osaka, Japan

Site Status

Pfizer Investigational Site

Osaka, Osaka, Japan

Site Status

Pfizer Investigational Site

Suita-shi,, Osaka, Japan

Site Status

Pfizer Investigational Site

Suita-shi, Osaka, Japan

Site Status

Pfizer Investigational Site

Toyonaka, Osaka, Japan

Site Status

Pfizer Investigational Site

Yodogawa-Ku, Osaka, Japan

Site Status

Pfizer Investigational Site

Saitama-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Satte-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Wakou-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Gotenbashi, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Susono, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chofu-shi, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Fucyushi, Tokyo, Japan

Site Status

Pfizer Investigational Site

Koto-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nakano-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nishi-Tokyo-shi, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setgaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shibuya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Suginami-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Sumida-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chuou-shi, Yamanashi, Japan

Site Status

Pfizer Investigational Site

Cheonan-si, Chungcheongnam-do, South Korea

Site Status

Pfizer Investigational Site

Pusan, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Chiayi Country, , Taiwan

Site Status

Pfizer Investigational Site

Hualien City, , Taiwan

Site Status

Pfizer Investigational Site

Koahsiung, , Taiwan

Site Status

Pfizer Investigational Site

Taichung, , Taiwan

Site Status

Pfizer Investigational Site

Taipei, , Taiwan

Site Status

Pfizer Investigational Site

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong Japan South Korea Taiwan

Related Links

Access external resources that provide additional context or updates about the study.

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

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0221005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
NCT00425100 COMPLETED PHASE3
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
NCT00928070 COMPLETED PHASE4
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
NCT01302067 COMPLETED PHASE4
UK Study Assessing Flexible Dose Fesoterodine in Adults
NCT00806494 COMPLETED PHASE4
Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
NCT00138723 COMPLETED PHASE3
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
NCT00611026 COMPLETED PHASE3
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
NCT02501928 COMPLETED PHASE3
A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
NCT00220363 COMPLETED PHASE3
Fesoterodine "add-on" Male Overactive Bladder Study
NCT00546637 COMPLETED PHASE3
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
NCT00444925 COMPLETED PHASE3
Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder
NCT01578304 COMPLETED PHASE4
This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder
NCT00943735 COMPLETED
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
NCT01302054 COMPLETED PHASE4
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
NCT01286454 COMPLETED PHASE1
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
NCT01557244 COMPLETED PHASE3
A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment
NCT02240459 COMPLETED PHASE2
Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
NCT01260311 COMPLETED
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
NCT01042236 COMPLETED PHASE2
A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
NCT03572231 COMPLETED
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects
NCT02821312 UNKNOWN PHASE1
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
NCT03602508 COMPLETED
A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder
NCT03566134 COMPLETED PHASE2
Extension Study of Fesoterodine for Overactive Bladder Syndrome in Children.
NCT02614482 COMPLETED PHASE3
Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
NCT03175029 COMPLETED PHASE2
Fesoterodine on Urgency Episodes in Parkinson's Disease Population
NCT02385500 TERMINATED PHASE4