Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 379
- Primary Endpoint
- Number of Participants With Any Serious Adverse Event
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pediatric patients prescribed valaciclovir
Pediatric patients with chickenpox prescribed valaciclovir during study period.
Intervention: Valaciclovir (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Number of Participants With the Indicated Adverse Drug Reactions(1 month)
- Number of Participants Classified as Effective and Not Effective(1 month)
- Number of Participants With Any Unexpected Adverse Drug Reactions(1 month)