At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 231 enrolled
Drug / intervention
tamsulosin hydrochloride +1 moredrug
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 IIb/III, Multi-centre, Double-blind, Randomised, Placebo-controlled, Dose Ranging Study of Tamsulosin Hydrochloride (Low, Medium and High Dose) as Treatment in Children With Neuropathic Bladder for Three Months
In Brief
A Phase 3 clinical trial evaluating tamsulosin hydrochloride and Placebo for Bladder, Neurogenic. Completed, enrolled 231 participants across 52 sites in 13 countries.
Detailed Summary
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder, Neurogenic
CountriesBelgium, Brazil, Germany, India, Italy, Mexico, Philippines, Russia, South Africa, South Korea, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedNov 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedNov 24, 2008
Enrollment StartJan 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.6 years ago
Interventions
tamsulosin hydrochloridedrug
Oral
Placebodrug
Oral