At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12 enrolled
Drug / intervention
Fesoterodine PR 4 mg +3 moredrug
Likely dose
Fesoterodine PR 4 mgfrom 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.
LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY OF FESOTERODINE IN JAPANESE PEDIATRIC SUBJECTS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY) WHO HAVE COMPLETED 24 WEEKS TREATMENT IN STUDY A0221047
In Brief
A Phase 3 clinical trial evaluating Fesoterodine PR 4 mg, Fesoterodine PR 8 mg, and 2 other interventions for Urinary Bladder, Neurogenic. Completed, enrolled 12 participants across 7 sites.
Detailed Summary
The purpose of this study is to investigate the safety and tolerability of fesoterodine following once daily long-term treatment in Japanese pediatric neurogenic detrusor overactivity (NDO) subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder, Neurogenic
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJul 2015
Primary CompletionApr 2020
TodayJul 2026
First PostedJul 17, 2015
Enrollment StartJun 5, 2015
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.0 years ago
Interventions
Fesoterodine PR 4 mgdrug
Fesoterodine 4 mg tablet once daily for 28 or 40 weeks
Fesoterodine PR 8 mgdrug
Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks
Fesoterodine BIC 2 mgdrug
Fesoterodine BIC 2 mg tablet once daily for 28 weeks
Fesoterodine BIC 4 mgdrug
Fesoterodine BIC 4 mg tablet once daily for 28 weeks