Neurogenic Detrusor Overactivity Clinical Trial
Official title:
A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
The NDO often occurs in patients with spina bifida or other spinal cord damage where the
bladder muscle contracts more than normal during filling. These patients often have an
inability to void, so that catheterization is required to empty the bladder.
The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets
are given to adults for the treatment of overactive bladder. A new liquid suspension has been
developed to treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension was investigated. The take-up and
length of time that the solifenacin suspension stays in the body was also investigated during
this study. Effectiveness was measured by urodynamics (the filling and emptying of the
bladder) and the urine volumes during catheterization together with the diary responses
relating to the number of incontinence episodes or incontinence free days.
Safety assessments included analysis of the blood and urine, review of the electrocardiogram
(ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function)
and the ability to see near and far objects (visual accommodation).
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