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Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

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ClinicalTrials.gov Identifier: NCT01390857
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : September 26, 2011
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox

Condition or disease Intervention/treatment
Varicella Drug: Valaciclovir

Study Type : Observational
Actual Enrollment : 379 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
Study Start Date : November 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pediatric patients prescribed valaciclovir
Pediatric patients with chickenpox prescribed valaciclovir during study period.
Drug: Valaciclovir



Primary Outcome Measures :
  1. Number of Participants With Any Serious Adverse Event [ Time Frame: 1 month ]
    A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.


Secondary Outcome Measures :
  1. Number of Participants With the Indicated Adverse Drug Reactions [ Time Frame: 1 month ]
    An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.

  2. Number of Participants With Any Unexpected Adverse Drug Reactions [ Time Frame: 1 month ]
    An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.

  3. Number of Participants Classified as Effective and Not Effective [ Time Frame: 1 month ]
    The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. "Improved" was regarded as "Effective," and "Unchanged" and " Worsen" were regarded as "Not effective." The two participants classifed as "Not effective" were classified as "Unchanged."



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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese pediatric patients with chickenpox (aged less than 15 years old)
Criteria

Inclusion Criteria:

  • Pediatric patients with chickenpox (aged less than 15 years old).

Exclusion Criteria:

  • Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390857


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01390857     History of Changes
Other Study ID Numbers: 112323
First Posted: July 11, 2011    Key Record Dates
Results First Posted: September 26, 2011
Last Update Posted: May 17, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents