A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex
Intervention: Valaciclovir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline
Summary
Limited data are available on valaciclovir use in children and valaciclovir is not currently
approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for
use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An
extemporaneous suspension formulation of valaciclovir has been developed to expedite the
provision of benefits to children similar to those from administration of valaciclovir solid
formulations in adults.
Clinical Details
Official title: An Open-Label, Single-Dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.
Secondary outcome: Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
Eligibility
Minimum age: 1 Month.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Subjects who have a current herpes virus infection.
- Have neonatally acquired herpes at risk of potential recurrence.
- Immunocompromised or cancer patients at risk for development of a herpes virus
infection.
Exclusion criteria:
- Hypersensitivity to antiherpetic medications.
- Impaired hepatic or renal function.
- Show presence of other serious or unstable underlying disease.
Locations and Contacts
GSK Clinical Trials Center, Santiago 4446, Chile
GSK Clinical Trials Center, Brits 0250, South Africa
GSK Clinical Trials Center, George 6529, South Africa
GSK Clinical Trials Center, Birmingham, Alabama 35233, United States
GSK Clinical Trials Center, Little Rock, Arkansas 72202-3591, United States
GSK Clinical Trials Center, San Diego, California 92123-4282, United States
GSK Clinical Trials Center, Los Angeles, California 90095, United States
GSK Clinical Trials Center, Jacksonville, Florida 32209, United States
GSK Clinical Trials Center, Louisville, Kentucky 40202, United States
GSK Clinical Trials Center, Lexington, Kentucky 40503, United States
GSK Clinical Trials Center, Louisville, Kentucky 40202, United States
GSK Clinical Trials Center, New Orleans, Louisiana 70112, United States
GSK Clinical Trials Center, Durham, North Carolina 27710, United States
GSK Clinical Trials Center, Cincinnati, Ohio 45229-3039, United States
GSK Clinical Trials Center, Galveston, Texas 77555-0371, United States
Additional Information
Starting date: December 2002
Last updated: June 9, 2008
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