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Evaluation Of Valaciclovir In Patients With Chickenpox

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Varicella

Intervention: valaciclovir HCl granules (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

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

Primary outcome: 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: 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.

Eligibility

Minimum age: 1 Year. Maximum age: 11 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: March 2005
Last updated: April 14, 2015

Page last updated: August 23, 2015

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