Urinary Bladder, Overactive Clinical Trial
Official title:
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
Solifenacin succinate as a tablet formulation is already on the market for the treatment of
symptoms of overactive bladder in adults. For the use in children and adolescent patients a
new formulation of solifenacin has been developed.
This study investigated the effect and safety of solifenacin succinate liquid suspension
compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the
double blind period was a single-blind placebo run-in period in combination with behavioral
urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder
(OAB) information, awareness, instruction, life-style advice and documentation of voiding
habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also
investigated how well solifenacin succinate suspension is taken-up by the body and how long
it stays in the body during this time.
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