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Fesoterodine Flexible Dose Study

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NCT00536484

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

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

- 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.

NCT00536484
Pfizer
Completed
Fesoterodine Flexible Dose Study

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Pfizer Clinical Trials Contact Center

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[email protected]

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Fesoterodine Flexible Dose Study
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.
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 tolerated.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: Fesoterodine
    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.
  • Drug: Placebo
    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.
  • Experimental: Fesoterodine (Double-Blind)
    Intervention: Drug: Fesoterodine
  • Placebo Comparator: Placebo (Double-Blind)
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
896
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00536484
A0221014
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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