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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Bladder, Neurogenic

Treatments: Drug: tamsulosin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00340704

527.66

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neuropathic bladder secondary to known neurological disorder
• Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 3 patient groups

1. Low dose group

Experimental group

Treatment:

Drug: tamsulosin hydrochloride

2. Medium dose group

Experimental group

Treatment:

Drug: tamsulosin hydrochloride

3. High dose group

Experimental group

Treatment:

Drug: tamsulosin hydrochloride