A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Completed
Astellas Pharma Europe B.V.
Phase 3
2012-06-07
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.
A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
Completed
Astellas Pharma Korea, Inc.
Phase 3
1969-12-31
The purpose of this study is to ascertain the clinical results of solifenacin succinate of
PIII study conducted in the original country using Korean patients with an overactive
bladder.
A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
Completed
Astellas Pharma Inc
Phase 3
1969-12-31
The purpose of this study is to ascertain the clinical results of solifenacin succinate of
PIII study conducted in the original country using Korean patients with an overactive
bladder.
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