Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 11-17 Years - Full Text View

Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 11-17 Years (A0221066)

This study is currently recruiting participants.

Verified by Pfizer, August 2009

First Received: February 26, 2009 Last Updated: August 17, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00857896

Purpose

The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 11-17 years, with overactive bladder.

Condition	Intervention	Phase
Overactive Bladder Neurogenic Detrusor Overactivity	Drug: Fesoterodine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 11-17 Years.

Resource links provided by NLM:

Drug Information available for: Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine the pharmacokinetics of 5-HMT in pediatric OAB subjects aged 11-17 years. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the influence of subject covariates on the pharmacokinetics of 5-HMT. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To assess the safety and tolerability of fesoterodine in pediatric OAB subjects aged 11-17 years. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine once daily: Experimental	Drug: Fesoterodine 4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A total body weight >35 kg (77 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857896

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Kansas
Pfizer Investigational Site	Recruiting
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site	Recruiting
Overland Park, Kansas, United States, 66212
United States, Louisiana
Pfizer Investigational Site	Recruiting
Shreveport, Louisiana, United States, 71106-8150
United States, Michigan
Pfizer Investigational Site	Recruiting
Troy, Michigan, United States, 48084
United States, Ohio
Pfizer Investigational Site	Recruiting
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221066
Study First Received:	February 26, 2009
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00857896 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Study of fesoterodine in pediatric overactive bladder patients

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on September 10, 2009