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

Phase 2

Completed

• Conditions: Overactive Bladder; Neurogenic Detrusor Overactivity
• Interventions: Drug: Fesoterodine

• Registration Number: NCT00857896
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-26
• Study Start: 2009-03
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-10-04
• Results First Submitted QC: 2011-10-04
• Status Verified: 2011-11
• Results First Posted: 2011-11-17
• Last Update Submitted: 2011-11-20
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fesoterodine once daily	Fesoterodine	-

Primary Outcome Measures

Name	Time	Method
Absorption Rate Constant (Ka)	Day 28 and Day 56
Apparent Volume of Distribution (VC/F)	Day 28 and Day 56	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.
Area Under the Plasma Drug Concentration Time Curve (AUC)	Day 28 and Day 56	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
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)	Day 28 and Day 56	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)	Day 28 and Day 56	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.

Secondary Outcome Measures

Name	Time	Method
Post-void Residual (PVR) Volume	Baseline, Week 4, and Week 8 post-dose	Volume of urine remaining in the bladder immediately after urination.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Liberty Township, Ohio, United States