Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder; Neurogenic Detrusor Overactivity
Intervention: Fesoterodine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021, Email: ClinicalTrials.gov_Inquiries@pfizer.com
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.
Clinical Details
Official title: An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the pharmacokinetics of 5-HMT in pediatric OAB subjects aged 8-17 years.
Secondary outcome: To examine the influence of subject covariates on the pharmacokinetics of 5-HMT.To assess the safety and tolerability of fesoterodine in pediatric OAB subjects aged 8-17 years.
Eligibility
Minimum age: 8 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021, Email: ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer Investigational Site, Little Rock, Arkansas 72204, United States; Not yet recruiting
Pfizer Investigational Site, Long Beach, California 90806, United States; Recruiting
Pfizer Investigational Site, Overland Park, Kansas 66211, United States; Completed
Pfizer Investigational Site, Overland Park, Kansas 66212, United States; Completed
Pfizer Investigational Site, Shreveport, Louisiana 71106-8150, United States; Completed
Pfizer Investigational Site, Troy, Michigan 48084, United States; Completed
Pfizer Investigational Site, Lincoln, Nebraska 68516, United States; Recruiting
Pfizer Investigational Site, Cincinnati, Ohio 45229, United States; Recruiting
Pfizer Investigational Site, Cleveland, Ohio 44106, United States; Completed
Pfizer Investigational Site, Liberty Township, Ohio 45044, United States; Recruiting
Pfizer Investigational Site, Philadelphia, Pennsylvania 19134, United States; Not yet recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2009
Last updated: September 9, 2010
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