NCT00297206

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

Completed Phase 1 Last updated 11 September 2017

What this trial tests

Phase 1 trial testing Valaciclovir in Herpes Simplex in 36 participants. Completed in 28 February 2007.

Timeline

25 January 2003

Primary endpoint
28 February 2007

28 February 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	25 January 2003
Primary completion	28 February 2007
Estimated completion	28 February 2007
Sites	13 locations across Chile, South Africa, United States

Drugs / interventions tested

• Valaciclovir (valaciclovir) — full drug profile →

Conditions studied

• Herpes Simplex — all drugs for Herpes Simplex →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 1 Month to 6, any sex, with Herpes Simplex. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age.
   Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, et al · · 2010 · cited 24× · PMID 20014952 · DOI 10.1086/649212