A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

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NCT01302067

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Study Location
Urology Centers of Alabama
Birmingham, Alabama, 35209, United States
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Contact
1-800-718-1021
[email protected]
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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
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

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


- Other concurrent and concomitant medication or disease that could put the subjects at
additional risk or interfere with the study results.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
Official Title  ICMJE A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.
Brief Summary This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Fesoterodine 8mg
    Oral, 1 tablet per day, 12 weeks duration, 8mg/day
  • Drug: Fesoterodine 4mg
    Oral, 1 tablet per day, 12 weeks duration, 4mg/day
  • Drug: Placebo
    Oral, 1 tablet per day, 12 weeks duration
Study Arms  ICMJE
  • Experimental: Fesoterodine 8mg
    Intervention: Drug: Fesoterodine 8mg
  • Experimental: Fesoterodine 4mg
    Intervention: Drug: Fesoterodine 4mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.

*   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: February 25, 2014)		2012
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2011)		1990
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion Criteria:

  • Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 Argentina,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Egypt,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Norway,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Sweden,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT01302067
Other Study ID Numbers  ICMJE A0221095
EIGHT
Has Data Monitoring Committee No
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 February 2014

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