Urinary Bladder, Overactive Clinical Trial
Official title:
A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB)
This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.
This is a multicenter, open-label, sequential, single ascending dose study. The study will
consist of three treatment groups in children and three treatment groups in adolescents,
targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state.
The study will be conducted in pediatric OAB patients to establish the single-dose PK and the
acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist
of at least six patients.
The study will start with the lowest dose group in adolescent patients (12 to 17 years). When
this group has completed the study, their safety and concentration data will be reviewed by a
Safety Review Committee. If no safety concerns are evident according to pre-specified
criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in
the intermediate dose group will be started simultaneously. When these groups have completed
the study, their safety data and drug concentration data will also be reviewed. If no safety
concerns occurred, enrollment of children in the intermediate dose group and of adolescents
in the highest dose group will be started simultaneously. Finally, after these groups
completed the study and no safety concerns occurred during associated data review, enrollment
of children in the highest dose group will start. Interim review of plasma exposure at lower
doses will be used to adjust the next higher doses administered, if necessary.
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