At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 148 enrolled
Drug / intervention
Solifenacin succinate suspensiondrug
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.
An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB)
In Brief
A Phase 3 clinical trial evaluating Solifenacin succinate suspension for Urinary Bladder, Overactive. Completed, enrolled 148 participants across 39 sites in 16 countries.
Detailed Summary
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder, Overactive
CountriesBelgium, Brazil, Canada, Denmark, Mexico, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartOct 2012
Primary CompletionOct 2014
TodayJul 2026
First PostedAug 1, 2012
Enrollment StartOct 4, 2012
Primary CompletionOct 8, 2014
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 13.9 years ago
Interventions
Solifenacin succinate suspensiondrug
Oral suspension