Evaluation Of Valaciclovir In Patients With Chickenpox

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169416
• Other study ID #: HS2101951
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: April 14, 2015
• Start date: March 2005
• Est. completion date: August 2005

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 11 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chickenpox
• Varicella

Intervention

Drug:
• valaciclovir HCl granules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.