Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
1 other identifier
interventional
21
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2009
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
November 17, 2011
CompletedNovember 24, 2011
November 1, 2011
1.8 years
February 26, 2009
October 4, 2011
November 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (1)
Post-void Residual (PVR) Volume
Baseline, Week 4, and Week 8 post-dose
Study Arms (1)
Fesoterodine once daily
EXPERIMENTALInterventions
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
Pfizer Investigational Site
Little Rock, Arkansas, 72204, United States
Pfizer Investigational Site
Long Beach, California, 90806, United States
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71106-8150, United States
Pfizer Investigational Site
Troy, Michigan, 48084, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45229, United States
Pfizer Investigational Site
Cleveland, Ohio, 44106, United States
Pfizer Investigational Site
Liberty Township, Ohio, 45044, United States
Related Publications (1)
Sano Y, Shoji S, Shahin M, Sweeney K, Darekar A, Malhotra BK. Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):257-269. doi: 10.1007/s13318-023-00818-8. Epub 2023 Mar 9.
PMID: 36892754DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2009
First Posted
March 9, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 24, 2011
Results First Posted
November 17, 2011
Record last verified: 2011-11