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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Urology Centers of Alabama
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
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.

NCT01302067
Pfizer
Completed
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

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A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • 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
  • Experimental: Fesoterodine 8mg
    Intervention: Drug: Fesoterodine 8mg
  • Experimental: Fesoterodine 4mg
    Intervention: Drug: Fesoterodine 4mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.
 
Completed
2012
November 2012
November 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Austria
 
NCT01302067
A0221095
EIGHT
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2014

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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