Evaluation Of Valaciclovir In Patients With Chickenpox

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: April 14, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Drug: valaciclovir HCl granules
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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.

Enrollment: 43
Study Start Date: March 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00169416

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169416     History of Changes
Other Study ID Numbers: HS2101951 
Study First Received: September 9, 2005
Last Updated: April 14, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
chicken pox

Additional relevant MeSH terms:
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016