Evaluation Of Valaciclovir In Patients With Chickenpox - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00169416

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
Chickenpox	Drug: valaciclovir HCl granules	Phase III

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:

MedlinePlus related topics: Chickenpox

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

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

Intervention Details:

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

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00169416 History of Changes
Other Study ID Numbers:	HS2101951
Study First Received:	September 9, 2005
Last Updated:	October 1, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

chicken pox
varicella
VZV
pharmacokinetics

Additional relevant MeSH terms:

Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir

Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012