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Evaluation Of Valaciclovir In Patients With Chickenpox

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169416
First Posted: September 15, 2005
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
September 9, 2005
September 15, 2005
April 15, 2015
March 2005
August 2005   (Final data collection date for primary outcome measure)
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Varicella
Drug: 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
43
August 2005
August 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00169416
HS2101951
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2015

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