Clinical Trial: Evaluation Of Valaciclovir In Patients With Chickenpox
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.
Brief Summary: This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Original Primary Outcome: Plasma aciclovir concentrations approximately 1 â 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Current Secondary Outcome: Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Original Secondary Outcome: Plasma valaciclovir concentrations approximately 1 â 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Information By: GlaxoSmithKline
Dates:
Date Received: September 9, 2005
Date Started: March 2005
Date Completion:
Last Updated: April 14, 2015
Last Verified: April 2015