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

Boehringer Ingelheim

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bladder, Neurogenic

Treatments: Drug: Placebo; Drug: tamsulosin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796614

527.51

Details and patient eligibility

About

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

Enrollment: 231 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks

Treatment:

Drug: Placebo

Low dose

Experimental group

Description:

Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Treatment:

Drug: tamsulosin hydrochloride

Medium dose

Experimental group

Description:

Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Treatment:

Drug: tamsulosin hydrochloride

High dose

Experimental group

Description:

Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Treatment:

Drug: tamsulosin hydrochloride