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
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