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NCT01390805 Clinical Trial

Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Genital Herpes Clinical Trial

Official title:
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01390805
Other study ID # 112319
Secondary ID
Status Completed
Phase N/A
First received July 7, 2011
Last updated May 15, 2017
Start date November 2006
Est. completion date March 2011

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 462
Est. completion date March 2011
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valaciclovir Hydrochloride.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir 1 year
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