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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390857
• Other study ID #: 112323
• 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
• 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.

Related Conditions & MeSH terms

• Chickenpox
• Varicella

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