Clinical Trial: 2 Week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Yrs) With Neurogenic Detrusor Overactivity

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: A 14-day, Open-label, Multicenter, Dose-escalating, Sequential Cohort Study to Evaluate Pharmacodynamics (Urodynamics) and Pharmacokinetics, Clinical Efficacy, Tolerability and Safety, Following Multi

Brief 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.

Detailed Summary:
Sponsor: Warner Chilcott

Current Primary Outcome: Change from baseline to day 14 in the urodynamic parameter "volume at first contraction", comparing multiple doses of darifenacin liquid oral suspension [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Comparing effect of multiple doses of darifenacin liquid oral suspension, on: • Urodynamic, pharmacokinetic, efficacy parameters • Safety, tolerability [ Time Frame: 14 days ]

Original Secondary Outcome: Same as current

Information By: Warner Chilcott

Dates:
Date Received: July 3, 2008
Date Started: October 2008
Date Completion: December 2019
Last Updated: January 22, 2015
Last Verified: January 2015