Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tamsulosin

Criteria

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