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Fesoterodine "add-on" Male Overactive Bladder Study

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder Syndrome
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men aged 40 years and above.

- On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at
least 6 weeks prior to screening (Visit 1).

- Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and
micturition-related urgency episodes >=3 episode/24 hours.

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

- Contraindication to fesoterodine (antimuscarinics).

- 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.

NCT00546637
Pfizer
Completed
Fesoterodine "add-on" Male Overactive Bladder Study

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Descriptive Information
Brief Title  ICMJE Fesoterodine "add-on" Male Overactive Bladder Study
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.
Brief SummaryTo evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder Syndrome
Intervention  ICMJE
  • Drug: Fesoterodine
    Fesoterodine 4mg or 8mg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Fesoterodine 4mg or 8mg
    Intervention: Drug: Fesoterodine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Not Provided


*   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 22, 2010)
947
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2007)
900
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion DateFebruary 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men aged 40 years and above.
  • On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
  • Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria:

  • Contraindication to fesoterodine (antimuscarinics).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   Colombia,   Germany,   Greece,   India,   Korea, Republic of,   Malaysia,   Netherlands,   Norway,   Philippines,   Poland,   Singapore,   Slovakia,   Spain,   Sweden,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00546637
Other Study ID Numbers  ICMJE A0221009
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer,Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2011

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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