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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Bladder, Neurogenic

In brief

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

Key facts

Study ID

NCT00796614

Run by

Boehringer Ingelheim

People needed

231

Starts

2008-01-01

Expected to finish

2009-02-01

Last updated by the study team

2015-10-29

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Clinically significant abnormalities as determined by the investigator
• A history of relevant orthostatic hypotension, fainting spells or blackouts

Where it is running

• Study site — Tampa, Florida, United States
• Study site — St Louis, Missouri, United States
• Study site — Buffalo, New York, United States
• Study site — Tarrytown, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Ghent, Belgium
• Study site — Santo André, Brazil
• Study site — São Paulo, Brazil
• Study site — Berlin, Germany
• Study site — Deggendorf, Germany
• Study site — Essen, Germany
• Study site — Hamburg, Germany
• Study site — Mainz, Germany
• Study site — Ahmedabad, India
• Study site — Belagavi, India
• Study site — Bengaluru, India
• Study site — Hyderabaad, India
• Study site — Kochi, India
• Study site — Lucknow, India
• Study site — Ludhiana, India
• Study site — Manipal, India
• Study site — Mumbai, India
• Study site — Nadiād, India
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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