Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Status and phase
Completed
Phase 3
Conditions
Recurrent Genital Herpes
Treatments
Drug: Famciclovir
Details and patient eligibility
About
This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes.
This study is not recruiting patients in the United States.
Enrollment
1,461 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosis of genital herpes
- Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months
Exclusion criteria
-
- Currently taking suppressive herpes antiviral therapy
- Females who are pregnant, breast feeding or planning to become pregnant during study
- History of allergy to famciclovir or similar products (e.g. aciclovir, valaciclovir)
Other protocol-defined exclusion criteria may apply.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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