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

Last updated on December 12, 2019

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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.
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- 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.
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- 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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Descriptive Information
Brief Title  ICMJE Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Official Title  ICMJE An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Overactive Bladder
  • Neurogenic Detrusor Overactivity
Intervention  ICMJE Drug: Fesoterodine
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
Study Arms  ICMJE Experimental: Fesoterodine once daily
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 Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2011)
21
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2009)
20
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00857896
Other Study ID Numbers  ICMJE A0221066
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2011

ICMJE     Data element required by the

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

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