Status:
COMPLETED
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Neurogenic Detrusor Overactivity
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00857896
Start Date
March 1 2009
End Date
December 1 2010
Last Update
November 24 2011
Active Locations (9)
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1
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72204
2
Pfizer Investigational Site
Long Beach, California, United States, 90806
3
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
4
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212