Evaluation Of Valaciclovir In Patients With Chickenpox

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.

Official Title

Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox – Open Uncontrolled Study.

Conditions

• Chicken Pox

Study Type

Interventional

Study Design

Treatment, Non-Randomised, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study.

Further Details

Primary Outcome Measures:

• 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.

Secondary Outcome Measures:

• 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.

Study Start

January 2005

Eligibility & Criteria

• Ages Eligible for Study: 1 year to 11 years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash

Exclusion criteria:

• History of hypersensitivity reactions
• Impaired hepatic or renal function
• Gastrointestinal dysfunction
• Serious underlying disease
• Weigh over 40kg
• Vaccinated for chickenpox

Total Enrolment

40

Contact Details

Location: 

GSK Clinical Trials Call Center
Toyoake, Japan