Clinical trial NCT00857896: Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Neurogenic Detrusor Overactivity
Keywords: Study of fesoterodine in pediatric overactive bladder patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absorption Rate Constant (Ka)
timeFrame: Day 28 and Day 56
measure: Apparent Volume of Distribution (VC/F)
timeFrame: Day 28 and Day 56
measure: Area Under the Plasma Drug Concentration Time Curve (AUC)
timeFrame: Day 28 and Day 56
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 28 and Day 56
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 28 and Day 56
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Day 28 and Day 56
measure: Apparent Oral Clearance (CL/F)
timeFrame: Day 28 and Day 56
Secondary outcomes:
measure: Post-void Residual (PVR) Volume
timeFrame: Baseline, Week 4, and Week 8 post-dose
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Liberty Township
country: United States
facility: Pfizer Investigational Site
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: