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

Study Overview
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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.

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

Conditions
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Overactive Bladder, Neurogenic Detrusor Overactivity

Intervention / Treatment
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* Drug: Fesoterodine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fesoterodine once daily<br> | Drug: Fesoterodine<br>* 4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorption Rate Constant (Ka) |  | 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. | 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. | Day 28 and Day 56 | 
| Maximum Observed Plasma Concentration (Cmax) |  | Day 28 and Day 56 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 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. | 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. | Day 28 and Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-void Residual (PVR) Volume | Volume of urine remaining in the bladder immediately after urination. | Baseline, Week 4, and Week 8 post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Study of fesoterodine in pediatric overactive bladder patients