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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Neurogenic Detrusor Overactivity; Overactive Bladder

Treatments: Drug: Fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857896

A0221066

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Fesoterodine once daily

Experimental group

Treatment:

Drug: Fesoterodine