NCT00340704

PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder, Neurogenic

Interventions

Type	Name	Description
DRUG	tamsulosin hydrochloride	oral

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2006-06-21
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

72 sites across 14 countries: United States, Belgium, Brazil, Canada, Germany, India, Italy, Mexico, Philippines, Russia, South Africa, South Korea, Spain, Ukraine