N/A
N=379
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
Varicella
Bottom Line
View on ClinicalTrials.gov: NCT01390857 ↗Enrolled (actual)
379
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Number of Participants With Any Serious Adverse Event — 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Valaciclovir (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Serious Adverse Event |
— | — |
| SECONDARY Number of Participants With the Indicated Adverse Drug Reactions |
2; 1 | — |
| SECONDARY Number of Participants With Any Unexpected Adverse Drug Reactions |
— | — |
| SECONDARY Number of Participants Classified as Effective and Not Effective |
347; 2 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01390857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.