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

A 14-day, Open-label, Multicenter, Dose-escalating, Sequential Cohort Study to Evaluate Pharmacodynamics (Urodynamics) and Pharmacokinetics, Clinical Efficacy, Tolerability and Safety Following Multiple Doses (mg/kg/Day) of a Darifenacin Liquid Oral Suspension Given BID in Children, Ages 2 - 15 Years, With Neurogenic Detrusor Overactivity

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	Darifenacin	Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.

Timeline

• Start date: 2008-10-07
• Primary completion: 2013-05-23
• Completion: 2013-05-23
• First posted: 2008-07-09
• Last updated: 2022-06-09
• Results posted: 2022-06-09

Locations

12 sites across 2 countries: United States, Colombia

Regulatory

• FDA-regulated drug study