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

Completed

• Conditions: Varicella
• Interventions: Drug: Valaciclovir

• Registration Number: NCT01390857
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-09
• Study Completion: 2010-05
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Results First Submitted: 2011-08-18
• Results First Submitted QC: 2011-08-18
• Results First Posted: 2011-09-26
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients prescribed valaciclovir	Valaciclovir	Pediatric patients with chickenpox prescribed valaciclovir during study period.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Any Serious Adverse Event	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

Name	Time	Method
Number of Participants With the Indicated Adverse Drug Reactions	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.
Number of Participants Classified as Effective and Not Effective	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."
Number of Participants With Any Unexpected Adverse Drug Reactions	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.