drugset / Trial / NCT01539707

Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

NCT01539707

Phase 1 Completed 14 enrolled Astellas Pharma Inc
Non-randomizedSingle-groupOpen-labelOther

Summary

The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.

Timeline

Start
2012-03-13
Primary completion
2012-08-13
Completion
2012-08-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Solifenacin Small molecule 5 mg Oral

Indications