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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fesoterodine

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