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Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72204 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder, Neurogenic Detrusor Overactivity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- A total body weight >25 kg (55 lbs).

- Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and
urgency to urinate, with or without urgency incontinence, for at least 6 months prior
to enrolment, OR

- Stable neurological disease and urodynamically confirmed detrusor overactivity, who
may require intermittent catheterization for management of urinary drainage.

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

- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is
longer, before first study dose

- Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors

- Ongoing use of another drug for treating overactive bladder

- Uncontrolled narrow angle glaucoma, urinary or gastric retention

NCT00857896
Pfizer
Completed
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years

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Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Overactive Bladder
  • Neurogenic Detrusor Overactivity
Drug: Fesoterodine
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
Experimental: Fesoterodine once daily
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
21
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A total body weight >25 kg (55 lbs).
  • Symptoms of urinary frequency (average ?8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR
  • Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.

Exclusion Criteria:

  • Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose
  • Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors
  • Ongoing use of another drug for treating overactive bladder
  • Uncontrolled narrow angle glaucoma, urinary or gastric retention
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00857896
A0221066
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 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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Contact

[email protected]



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