Evaluation Of Valaciclovir In Patients With Chickenpox

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169416
First received: September 9, 2005
Last updated: April 11, 2013
Last verified: May 2012
  Purpose

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
Varicella
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.

Estimated Enrollment: 40
Study Start Date: March 2005
Intervention Details:
    Drug: valaciclovir HCl granules
    Other Name: valaciclovir HCl granules
  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169416     History of Changes
Other Study ID Numbers: HS2101951
Study First Received: September 9, 2005
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
chicken pox
varicella
VZV
pharmacokinetics

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014