NCT01981954

A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

A Phase 3, Open-Label, Baseline-controlled, Multi-center, Sequential Dose-Titration Study to Assess the Pharmacokinetics, Long-Term Efficacy and Safety of Solifenacin Succinate Suspension in Children From 6 Months to Less Than 5 Years of Age With Neurogenic Detrusor Overactivity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 6 Months – 4 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.

Detailed description

In some children with a severe form of spina bifida (which is the consequence of a spinal cord defect), the bladder muscle (detrusor) contracts strongly and without warning (also known as neurogenic detrusor overactivity) and the urethra (the passage connecting the bladder with outside) does not relax. Though these children cannot void, urine leakage can happen when the overactive contractions are strong, and/or the pressure in the bladder is so high that it overcomes the closed urethra (overflow at high filling bladder pressure). This high bladder pressure puts these children at risk for kidney damage and can decrease the quality of the bladder. Therapy was aimed to decrease the high filling bladder pressure and the overactive detrusor contractions.

Conditions

• Neurogenic Detrusor Overactivity
• Pediatric

Interventions

Type	Name	Description
DRUG	Solifenacin succinate	Oral suspension

Timeline

• Start date: 2013-09-25
• Primary completion: 2015-12-18
• Completion: 2015-12-18
• First posted: 2013-11-13
• Last updated: 2024-10-31
• Results posted: 2018-06-21

Locations

8 sites across 6 countries: United States, Belgium, Philippines, Poland, South Korea, United Kingdom