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.

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.

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