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

Pfizer21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overactive Bladder Neurogenic Detrusor Overactivity

Interventions

FesoterodineDRUG

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (9)

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

Outcomes

Primary Outcomes

Absorption Rate Constant (Ka)

Time frame: Day 28 and Day 56

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.

Time frame: Day 28 and Day 56

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.

Time frame: Day 28 and Day 56

Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 28 and Day 56

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: Day 28 and Day 56

Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Day 28 and Day 56

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.

Time frame: Day 28 and Day 56

Secondary Outcomes

Post-void Residual (PVR) Volume

Data from ClinicalTrials.gov

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