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A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

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NCT00425100

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Homewood, Alabama, 35209 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per
24 h documented in the baseline bladder diary)

- OAB patients dissatisfied with their prior therapy with tolterodine

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

- Patients with any contraindication to fesoterodine usage, e.g., urinary retention,
gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to
the drug or its ingredients.

- Patients with significant hepatic and renal disease or other significant unstable
diseases.

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

NCT00425100
Pfizer
Completed
A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

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[email protected]

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A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.
To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Overactive Bladder
Drug: fesoterodine fumarate
12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.
Experimental: Open Label-fesoterodine
Single treatment study arm.
Intervention: Drug: fesoterodine fumarate
Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
October 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • OAB patients who present with OAB symptoms(?8 micturitions and ?3 urgency episodes per 24 h documented in the baseline bladder diary)
  • OAB patients dissatisfied with their prior therapy with tolterodine

Exclusion Criteria:

  • Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
  • Patients with significant hepatic and renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Costa Rica,   Czech Republic,   Germany,   Korea, Republic of,   Poland,   Slovakia,   Ukraine,   United States
Norway
 
NCT00425100
A0221007
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

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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