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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01390857
Other study ID # 112323
Secondary ID
Status Completed
Phase N/A
First received July 7, 2011
Last updated May 15, 2017
Start date November 2007
Est. completion date May 2010

Study information

Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 379
Est. completion date May 2010
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender All
Age group N/A to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Valaciclovir


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Any Serious Adverse Event 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. 1 month
Secondary Number of Participants With the Indicated Adverse Drug Reactions 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. 1 month
Secondary Number of Participants With Any Unexpected Adverse Drug Reactions 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. 1 month
Secondary Number of Participants Classified as Effective and Not Effective 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." 1 month
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