Last updated: 11/07/2018 04:42:30
Special Drug Use Investigation for VALTREX (Valaciclovir) (suppression prophylaxis)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for VALTREX (Valaciclovir) (suppression prophylaxis)
Trial description: The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Valaciclovir Hydrochloride.
Enrollment:
462
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Takashi Kawana, Mariko Honda, Hideyuki Okano, Yuko Suzuki, Shogo Inoshiri, Shoichi Onodera. Valaciclovir Hydrochloride (Valtrex® Tablets 500 / Valtrex® Granules 50%) for the Suppression of Recurrent Genital Herpes: A Special Drug Use Investigation in Japan. [Jpn J Sex Trans Dis]. 2012;23(1):108-118.
Medical condition
Genital Herpes
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
November 2006 to March 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Subjects who started suppressive therapy for recurrent genital herpes for the first time
- Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who started suppressive therapy for recurrent genital herpes for the first time
Exclusion criteria:
- Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir
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
Not applicable
Actual study completion date
2011-31-03
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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