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
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||379 participants|
|Official Title:||Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)|
|Study Start Date :||November 2007|
|Primary Completion Date :||September 2008|
|Study Completion Date :||May 2010|
Pediatric patients prescribed valaciclovir
Pediatric patients with chickenpox prescribed valaciclovir during study period.
- 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.
- 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.
- 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.
- 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."
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
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|