Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Completed · Phase 2
Conditions studied: Overactive Bladder, Neurogenic Detrusor Overactivity
In brief
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.
Key facts
- Study ID
- NCT00857896
- Run by
- Pfizer
- People needed
- 21
- Starts
- 2009-03-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2011-11-24
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Pfizer Investigational Site — Little Rock, Arkansas, United States
- Pfizer Investigational Site — Long Beach, California, United States
- Pfizer Investigational Site — Overland Park, Kansas, United States
- Pfizer Investigational Site — Overland Park, Kansas, United States
- Pfizer Investigational Site — Shreveport, Louisiana, United States
- Pfizer Investigational Site — Troy, Michigan, United States
- Pfizer Investigational Site — Cincinnati, Ohio, United States
- Pfizer Investigational Site — Cleveland, Ohio, United States
- Pfizer Investigational Site — Liberty Township, Ohio, United States
Full record on ClinicalTrials.gov
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