A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
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...
Brief Summary
Official Title: “An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.”
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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Related Publications
References
Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00297206
