Evaluation Of Valaciclovir In Patients With Chickenpox

Last updated: April 14, 2015
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Chickenpox (Varicella Zoster Infection)

Herpes Simplex Infections

Throat And Tonsil Infections

Treatment

N/A

Clinical Study ID

NCT00169416
HS2101951
  • Ages 1-11
  • All Genders

Study Summary

This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpoxwithin 48 hours of the onset of the rash.

Exclusion

Exclusion criteria:

  • History of hypersensitivity reactions.

  • Impaired hepatic or renal function.

  • Gastrointestinal dysfunction.

  • Serious underlying disease.

  • Weigh over 40kg.

  • Vaccinated for chickenpox.

Study Design

Total Participants: 43
Study Start date:
March 01, 2005
Estimated Completion Date:
August 31, 2005