NCT01539707

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

A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder
• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	Solifenacin succinate suspension 5 mg	Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

Timeline

• Start date: 2012-03-13
• Primary completion: 2012-08-13
• Completion: 2012-08-13
• First posted: 2012-02-27
• Last updated: 2024-10-22

Locations

7 sites across 7 countries: Belgium, Canada, Denmark, Netherlands, Poland, Turkey (Türkiye), United Kingdom