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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.

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Wien, , 1090 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00798434
Pfizer
Completed
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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Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE
  • Drug: Placebo
    placebo administered orally in the morning or evening.
  • Drug: Fesoterodine fumarate
    Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.
    Other Name: Toviaz
Study Arms  ICMJE
  • Active Comparator: Placebo
    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.
    Intervention: Drug: Placebo
  • Active Comparator: Fesoterodine
    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.
    Intervention: Drug: Fesoterodine fumarate
Publications *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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2010)
794
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)
550
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion DateSeptember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Finland,   Germany,   Israel,   Italy,   Norway,   Portugal,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798434
Other Study ID Numbers  ICMJE A0221045
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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