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

NCT ID: NCT00857896

Last Updated: 2011-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Overactive Bladder Neurogenic Detrusor Overactivity

Keywords

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Study of fesoterodine in pediatric overactive bladder patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fesoterodine once daily

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

Interventions

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Fesoterodine

4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Little Rock, Arkansas, United States

Site Status

Pfizer Investigational Site

Long Beach, California, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Shreveport, Louisiana, United States

Site Status

Pfizer Investigational Site

Troy, Michigan, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Liberty Township, Ohio, United States

Site Status

Countries

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United States

References

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Sano Y, Shoji S, Shahin M, Sweeney K, Darekar A, Malhotra BK. Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):257-269. doi: 10.1007/s13318-023-00818-8. Epub 2023 Mar 9.

Reference Type DERIVED
PMID: 36892754 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221066&StudyName=Study%20Of%20Fesoterodine%20In%20Pediatric%20Overactive%20Bladder%20Patients%20Aged%208-17%20Years

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Other Identifiers

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A0221066

Identifier Type: -

Identifier Source: org_study_id