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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 November 21, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
?a?a, , Slovakia
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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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Descriptive Information
Brief TitleStudy In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
Official TitleObservational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.
Brief SummaryThis 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.
Detailed Descriptionpatients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationpatients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
Condition
  • Overactive Bladder
  • Urinary Incontinence
InterventionDrug: fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
Other Name: TOVIAZ
Study Groups/Cohortsfesoterodine
Not Specified
Intervention: Drug: fesoterodine
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: October 21, 2010)		823
Original Estimated Enrollment
 (submitted: June 4, 2008)		700
Actual Study Completion DateJune 2009
Actual Primary Completion DateJune 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSlovakia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00691093
Other Study ID NumbersA0221059
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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