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
- NCT00796614
- PHASE2
- INTERVENTIONAL
Last updated: 2015-10-29
Purpose of Trial
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
This study is for people with
Bladder, Neurogenic
Interventions being studied
tamsulosin hydrochloride
Placebo
Inclusion Criteria:
* Neuropathic bladder secondary to a known neurologic deficit (e.g. spina bifida)
* Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements
Exclusion Criteria:
* Clinically significant abnormalities as determined by the investigator
* A history of relevant orthostatic hypotension, fainting spells or blackouts
ELIGIBILITY
Gender: ALL
Age: 2+
Healthy Volunteers: No
7 Locations
Los Angeles
California, 90027, United States
Tampa
Florida, 33614, United States
St Louis
Missouri, 63110, United States
Buffalo
New York, 14222, United States
Tarrytown
New York, 10591, United States
Winston Salem
North Carolina, 27157, United States
Akron
Ohio, 44308, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov