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

NCT00561951

Last updated date
Study Location
Pfizer Investigational Site
Kowloon, , , Hong Kong
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
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Official Title  ICMJE A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.
Brief Summary To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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 fumarate
    8mg tablets OD for 12 weeks
  • Drug: Placebo
    Corresponding placebo tablets OD for 12 weeks
  • Drug: fesoterodine fumarate
    4mg tablets OD for 12 weeks
Study Arms  ICMJE
  • Experimental: Fesoterodine fumarate 4 mg (Double-Blind)
    Intervention: Drug: fesoterodine fumarate
  • Placebo Comparator: Placebo (Double-Blind)
    Intervention: Drug: Placebo
  • Experimental: Fesoterodine fumarate 8 mg (Double-Blind)
    Intervention: Drug: fesoterodine fumarate
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: August 18, 2010)
951
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2007)
900
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Hong Kong,   Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00561951
Other Study ID Numbers  ICMJE A0221005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2011

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