Last updated: 11/07/2018 04:43:12
Special Drug Use Investigation for VALTREX (valaciclovir) (Pediatrics Chickenpox)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for VALTREX (valaciclovir) (Pediatrics Chickenpox)
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with any serious adverse event
Timeframe: 1 month
Secondary outcomes:
Number of participants with the indicated adverse drug reactions
Timeframe: 1 month
Number of participants with any unexpected adverse drug reactions
Timeframe: 1 month
Number of participants classified as effective and not effective
Timeframe: 1 month
Interventions:
Drug: Valaciclovir
Enrollment:
379
Observational study model:
Other
Primary completion date:
2011-28-02
Time perspective:
Prospective
Clinical publications:
Hiroharu Abe, Hideyuki Okano, Terufumi Hara, Pascal Yoshida. Report on Results of Post-marketing Surveillance for Valaciclovir Hydrochloride (Valtrex®) ~ from Special Drug Use Investigation in Pediatric Patients with Chickenpox ~. J Clin Therapeut Med. 2012;28(12):1193-1203.
Medical condition
Varicella
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
November 2007 to February 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 14 years
Accepts healthy volunteers
No
- Pediatric patients with chickenpox (aged less than 15 years old).
- Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.
Inclusion and exclusion 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.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2011-28-02
Actual study completion date
2011-28-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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