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

Overactive Bladder Clinical Trial

Official title:

An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857896
• Other study ID #: A0221066
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2009
• Last updated: November 20, 2011
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurogenic Detrusor Overactivity
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Liberty Township	Ohio
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absorption Rate Constant (Ka)		Day 28 and Day 56	No
Primary	Apparent Volume of Distribution (VC/F)	The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.	Day 28 and Day 56	No
Primary	Area Under the Plasma Drug Concentration Time Curve (AUC)	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	Day 28 and Day 56	No
Primary	Maximum Observed Plasma Concentration (Cmax)		Day 28 and Day 56	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Day 28 and Day 56	No
Primary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 28 and Day 56	No
Primary	Apparent Oral Clearance (CL/F)	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.	Day 28 and Day 56	No
Secondary	Post-void Residual (PVR) Volume	Volume of urine remaining in the bladder immediately after urination.	Baseline, Week 4, and Week 8 post-dose	No

External Links

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