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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Enterprise, Alabama, 36330 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

- Adult subjects with overactive bladder symptoms (subject-reported) for greater than or
equal to 3 months prior to Screening/Enrollment visit.

- Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary
prior to the Randomization/Baseline visit

- Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as
verified by the 3-day bladder diary prior to randomization/Baseline visit.

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

- Subjects with any condition that would contraindicate their usage of fesoterodine
including: hypersensitivity to the active substance (fesoterodine fumarate) or to
peanut or soya or any of the excipients, urinary retention, gastric retention,
uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment
(Child Pugh C), severe ulcerative colitis, and toxic megacolon.

- Subjects with clinically significant hepatic or renal disease or other significant
unstable diseases.

- OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
etc.

- Subjects with previous history of acute urinary retention requiring catheterization,
or severe voiding difficulties in the judgment of the investigator, prior to baseline.

NCT00611026
Pfizer
Completed
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: Tolterodine ER
    The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
  • Drug: Placebo
    Placebo treatment will be once daily(QD) for 12 weeks.
  • Drug: Fesoterodine
    The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
  • Active Comparator: 1
    Intervention: Drug: Tolterodine ER
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 3
    Intervention: Drug: Fesoterodine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2417
October 2009
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
  • Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
  • Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

  • Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
  • Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
  • Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Bulgaria,   Canada,   Colombia,   Costa Rica,   Estonia,   Germany,   Greece,   Hungary,   India,   Ireland,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United States
 
 
NCT00611026
A0221046
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the

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

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