At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 143 enrolled
Drug / intervention
tamsulosin hydrochloridedrug
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 Uncontrolled, Open-label, Titration, Long-term Safety (up to 12 Months) and Efficacy Study of Tamsulosin Hydrochloride in Children With Neuropathic Bladder, With a Randomized Pharmacokinetic Sub-study Investigating Low, Medium and High Dose Ranges.
In Brief
A Phase 2 clinical trial evaluating tamsulosin hydrochloride for Bladder, Neurogenic. Completed, enrolled 143 participants across 72 sites in 14 countries.
Detailed Summary
Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder, Neurogenic
CountriesBelgium, Brazil, Canada, Germany, India, Italy, Mexico, Philippines, Russia, South Africa, South Korea, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedJun 2006
Primary CompletionJun 2009
TodayJul 2026
First PostedJun 21, 2006
Enrollment StartApr 1, 2006
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.0 years ago
Interventions
tamsulosin hydrochloridedrug
oral