Evaluation Of Valaciclovir In Patients With Chickenpox

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Varicella

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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valaciclovir HCl granules

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No