A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

NCT00928070

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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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
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- male or female subjects 65 years of age or older

- OAB symptoms for at least 3 months

- score 3 or greater on Vulnerable Elderly Survey (VES-13)

- adequate mobility for independent toileting

- mean number of at least 2 UUI episodes per 24 hours

- mean urinary frequency of 8 or more micturitions per 24 hours

- able to independently complete the bladder diaries

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


- PVR urinary volume greater than 200 ml


- MMSE score less than 20


- greater than 15 UUI episodes per 24 hours


- creatinine clearance less than 30 ml/min


- an average resting heart rate of greater than or equal to 90 beats per minute

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
Official Title  ICMJE A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.
Brief Summary This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Fesoterodine
    Fesoterodine 4 mg and 8 mg
  • Drug: Placebo
    Placebo sham 4 mg and 8 mg
Study Arms  ICMJE
  • Experimental: Fesoterodine
    Intervention: Drug: Fesoterodine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Dubeau CE, Kraus SR, Griebling TL, Newman DK, Wyman JF, Johnson TM 2nd, Ouslander JG, Sun F, Gong J, Bavendam T. Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial. J Urol. 2014 Feb;191(2):395-404. doi: 10.1016/j.juro.2013.08.027. Epub 2013 Aug 21.

*   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: October 20, 2011)
566
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2009)
610
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female subjects 65 years of age or older
  • OAB symptoms for at least 3 months
  • score 3 or greater on Vulnerable Elderly Survey (VES-13)
  • adequate mobility for independent toileting
  • mean number of at least 2 UUI episodes per 24 hours
  • mean urinary frequency of 8 or more micturitions per 24 hours
  • able to independently complete the bladder diaries

Exclusion Criteria:

  • PVR urinary volume greater than 200 ml
  • MMSE score less than 20
  • greater than 15 UUI episodes per 24 hours
  • creatinine clearance less than 30 ml/min
  • an average resting heart rate of greater than or equal to 90 beats per minute
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928070
Other Study ID Numbers  ICMJE A0221049
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP