NCT00169416

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

September 9, 2005

Last Update Submit

April 14, 2015

Conditions

Varicella

Keywords

chicken poxvaricellaVZVpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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.

Interventions

valaciclovir HCl granulesDRUG

Eligibility Criteria

Age1 Year - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • History of hypersensitivity reactions.
  • Impaired hepatic or renal function.
  • Gastrointestinal dysfunction.
  • Serious underlying disease.
  • Weigh over 40kg.
  • Vaccinated for chickenpox.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

April 15, 2015

Record last verified: 2015-04