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...
Date First Received: February 24, 2006
Last Updated: June 9, 2008
Verified by: GlaxoSmithKline, June 2008
Clinical Trial Phase: Phase 1 | Start Date: December 2002
Overall Status: Completed
Estimated Enrollment: 36
Brief Summary
Official Title: “An Open-Label, Single-Dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: Valaciclovir
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Month
Maximum Age for this Clinical Trial: 6 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Chair GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00297206
Study ID Number: HS210914
ClinicalTrials.gov Identifier: NCT00297206
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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