Back to resultsEvaluation Of Valaciclovir In Patients With Chickenpox
Primary Purpose
Varicella
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
valaciclovir HCl granules
Sponsored by
About this trial
This is an interventional treatment trial for Varicella focused on measuring chicken pox, varicella, VZV, pharmacokinetics
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00169416
Brief Title
Evaluation Of Valaciclovir In Patients With Chickenpox
Official Title
Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
chicken pox, varicella, VZV, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valaciclovir HCl granules
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation Of Valaciclovir In Patients With Chickenpox
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