Evaluation Of Valaciclovir In Patients With Chickenpox

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169416
First received: September 9, 2005
Last updated: April 11, 2013
Last verified: May 2012

September 9, 2005
April 11, 2013
March 2005
Not Provided
Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Plasma aciclovir concentrations approximately 1 â 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Complete list of historical versions of study NCT00169416 on ClinicalTrials.gov Archive Site
Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Plasma valaciclovir concentrations approximately 1 â 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Not Provided
Not Provided
 
Evaluation Of Valaciclovir In Patients With Chickenpox
Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Varicella
Drug: valaciclovir HCl granules
Other Name: valaciclovir HCl granules
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
Not Provided

Inclusion criteria:

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

Exclusion criteria:

  • History of hypersensitivity reactions.
  • Impaired hepatic or renal function.
  • Gastrointestinal dysfunction.
  • Serious underlying disease.
  • Weigh over 40kg.
  • Vaccinated for chickenpox.
Both
1 Year to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00169416
HS2101951
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP