Evaluating the safety and effectiveness of darifenacin in children (2-15) with neurogenic bladder

Description:
Urination, while a seemingly simple bodily function, requires coordination between various parts of the body such as the bladder, urethra, neurons and brain. At times, there can be a problem with this coordination that leads to a variety of problems. This study is evaluating the use of darifenacin liquid in patients with one of these problems known as neurogenic detrusor overactivity.

Medication Under Study:
darifenacin (Enablex®)

Full study title:
A 14-day, open-label, multicenter, dose-escalating, sequential
cohort study to evaluate pharmacodynamics (urodynamics) and pharmacokinetics, clinical efficacy, tolerability and safety, following multiple doses (mg/kg/day) of a darifenacin liquid oral suspension given b.i.d. in children, ages 2 - 15 years, with neurogenic detrusor overactivity

IRB Study ID:
081109


Who may qualify:

Patients 2-15 years old with neurogenic detrusor overactivity

Who does not qualify:

Patients who are unable to take the study medication or taking certain medications

If you are interested in this study or have questions about your child's eligibility, please contact:

Rebecca D. Considine Research Institute, 330-543-5012

For urgent patient care matters involving a current study patient, please call: 330-920-5774


Lead Principal Investigator:

Photo
Daniel McMahon MD
Director, Pediatric Urology


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