Recurrent Genital Herpes
Conditions
Keywords
genital herpes, herpes, famciclovir
Brief summary
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.
Interventions
DRUGFamciclovir
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessed by AEs. | — |
| Time between recurrences of genital herpes. | — |
| Proportion of aborted (i.e. lesions did not appear)genital herpes recurrences. Change from baseline in symptoms or impairment. Change form baseline in functioning or disability. | — |
Countries
Australia
Outcome results
None listed