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Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

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NCT00691093

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
?a?a, , Slovakia
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, Urinary Incontinence
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

- Patients older than 18 years

- Patients with OAB after failure of previous antimuscarinic therapy - due to lack of
efficacy: persistence of storage symptoms.

- Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2
per day subjectively perceived as bothersome

- Due to intolerance: persistent and/or unacceptable adverse events

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

- Hypersensitivity to the active substance or to peanut or soya or any of the
excipients.

- History of acute urinary retention (requiring catheterisation)

- Gastric retention

- Uncontrolled narrow angle glaucoma

- Myasthenia gravis

- Severe hepatic impairment (Child Pugh C)

- Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe
hepatic or renal impairment

- Severe ulcerative colitis

- Toxic megacolon.

NCT00691093
Pfizer
Completed
Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

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[email protected]

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Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.
This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.
patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
  • Overactive Bladder
  • Urinary Incontinence
Drug: fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
Other Name: TOVIAZ
Not Specified
Not Specified
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
823
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 18 years
  • Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
  • Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ?2 per day subjectively perceived as bothersome
  • Due to intolerance: persistent and/or unacceptable adverse events

Exclusion Criteria:

  • Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
  • History of acute urinary retention (requiring catheterisation)
  • Gastric retention
  • Uncontrolled narrow angle glaucoma
  • Myasthenia gravis
  • Severe hepatic impairment (Child Pugh C)
  • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
  • Severe ulcerative colitis
  • Toxic megacolon.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
 
NCT00691093
A0221059
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 2011

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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