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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00297206 |
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.
Condition | Intervention | Phase |
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Herpes Simplex |
Drug: Valaciclovir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Single-Dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children. |
Estimated Enrollment: | 36 |
Study Start Date: | January 2003 |
Ages Eligible for Study: | 1 Month to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, Alabama | |
GSK Investigational Site | |
Birmingham, Alabama, United States, 35233 | |
United States, Arkansas | |
GSK Investigational Site | |
Little Rock, Arkansas, United States, 72202 | |
United States, California | |
GSK Investigational Site | |
San Diego, California, United States, 92123 | |
United States, Florida | |
GSK Investigational Site | |
Jacksonville, Florida, United States, 32209 | |
United States, Kentucky | |
GSK Investigational Site | |
Louisville, Kentucky, United States, 40202 | |
GSK Investigational Site | |
Lexington, Kentucky, United States, 40503 | |
United States, Louisiana | |
GSK Investigational Site | |
New Orleans, Louisiana, United States, 70112 | |
United States, North Carolina | |
GSK Investigational Site | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
GSK Investigational Site | |
Cincinnati, Ohio, United States, 45229 | |
United States, Texas | |
GSK Investigational Site | |
Galveston, Texas, United States, 77555-0653 | |
Chile, Región Metro De Santiago | |
GSK Investigational Site | |
Santiago, Región Metro De Santiago, Chile | |
South Africa | |
GSK Investigational Site | |
George, South Africa, 6529 | |
GSK Investigational Site | |
Brits, South Africa, 2000 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | HS210914 |
Study First Received: | February 24, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00297206 |
Health Authority: | United States: Food and Drug Administration |
pharmacokinetics
herpes
varicella
herpes labialis
Epstein-Barr virus |
Valacyclovir Virus Diseases Herpes Zoster Herpes Simplex Skin Diseases, Infectious Skin Diseases |
Chickenpox DNA Virus Infections Chicken pox Herpesviridae Infections Herpes Labialis |
Skin Diseases, Viral Anti-Infective Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |