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drugset / Trial / NCT00712322

A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity

NCT00712322 ↗

Phase 2 Terminated 35 enrolled Warner Chilcott
Non-randomizedSequentialOpen-labelTreatment

Summary

This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.

Timeline

Start
2008-10-07
Primary completion
2013-05-23
Completion
2013-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Darifenacin Small molecule 0.03 mg/kg Oral
Subject Darifenacin Small molecule 0.0625 mg/kg Oral
Subject Darifenacin Small molecule 0.125 mg/kg Oral

Indications

overactive bladder