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Darifenacin PK/PD in pediatric neurogenic detrusor overactivity

NCT00712322Phase 2

Key facts

Status: Terminated
Start: Oct 2008
Primary completion: May 2013
Countries: 2
Sponsor: Warner Chilcott
Modality: Small Molecules

Drugs: darifenacin
Conditions: neurogenic detrusor overactivity (NDO)

Overview

Phase 2, open-label trial of darifenacin in neurogenic detrusor overactivity (NDO) (3 cohorts), sponsored by Warner Chilcott. Primary endpoint: Change From Baseline in Mean Maximum Bladder Capacity (MBC) at 14 days. Started Oct 2008; status: terminated.

Design

3 arms

Study design: Non-randomizedOpen-label

Cohort 1
Darifenacin 0.030 mg/kg/day
Cohort 2
Darifenacin 0.0625 mg/kg/day
Cohort 3
Darifenacin 0.125 mg/kg/day

Who it enrols

Children 2-15 years with neurogenic detrusor overactivity using clean intermittent catheterization. Excludes those with fecal impaction, significant anatomical abnormalities, or symptomatic UTI.

Endpoints

Primary

Change From Baseline in Mean Maximum Bladder Capacity (MBC)14 days

Secondary

Change From Baseline in Mean Volume at First Contraction14 days
Change From Baseline in Detrusor Pressure at First Contraction14 days
Change From Baseline in Mean Volume at First Detectable Leakage14 days
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure14 days
Change From Baseline in Mean Catheterization Volume14 days
Change From Baseline in Total Pad Weight In-between Catheterizations14 days

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