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A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
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 Director, 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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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 Investigational Site, Brits 2000, South Africa

GSK Investigational Site, George 6529, South Africa

GSK Investigational Site, Birmingham, Alabama 35233, United States

GSK Investigational Site, Little Rock, Arkansas 72202, United States

GSK Investigational Site, San Diego, California 92123, United States

GSK Investigational Site, Jacksonville, Florida 32209, United States

GSK Investigational Site, Lexington, Kentucky 40503, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, New Orleans, Louisiana 70112, United States

GSK Investigational Site, Durham, North Carolina 27705, United States

GSK Investigational Site, Cincinnati, Ohio 45229, United States

GSK Investigational Site, Santiago, RegiĆ³n Metro De Santiago 7580206, Chile

GSK Investigational Site, Galveston, Texas 77555-0653, United States

Additional Information

Related publications:

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. doi: 10.1086/649212.

Bradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease

Starting date: January 2003
Last updated: March 17, 2011

Page last updated: August 23, 2015

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