At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 23 enrolled
Drug / intervention
Solifenacin succinatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Solifenacin succinate for Neurogenic Detrusor Overactivity and Pediatric. Completed, enrolled 23 participants across 8 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurogenic Detrusor Overactivity, Pediatric
CountriesBelgium, Philippines, Poland, South Korea, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedNov 2013
Primary CompletionDec 2015
TodayJul 2026
First PostedNov 13, 2013
Enrollment StartSep 25, 2013
Primary CompletionDec 18, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.6 years ago
Interventions
Solifenacin succinatedrug
Oral suspension