Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Phase 3
Completed
- Conditions
- Recurrent Genital Herpes
- Registration Number
- NCT00171990
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1461
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
- Secondary Outcome Measures
Name Time Method 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. Safety and tolerability assessed by AEs.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇦🇺North Ryde, Australia