At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 76 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, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
In Brief
A Phase 3 clinical trial evaluating Solifenacin succinate for Neurogenic Detrusor Overactivity. Completed, enrolled 76 participants across 21 sites in 10 countries.
Detailed Summary
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurogenic Detrusor Overactivity
CountriesBelgium, Brazil, Denmark, Hungary, Mexico, Philippines, Poland, South Korea, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartAug 2012
Primary CompletionApr 2016
TodayJul 2026
First PostedMar 29, 2012
Enrollment StartAug 14, 2012
Primary CompletionApr 28, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.3 years ago
Interventions
Solifenacin succinatedrug
Oral suspension administered once a day via syringe.