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

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
Kowloon, , Hong Kong
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
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.

NCT00561951
Pfizer
Completed
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

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Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
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.
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
951
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Japan,   Korea, Republic of,   Taiwan
 
 
NCT00561951
A0221005
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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