Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT00306787
- Phase
- PHASE3
- Status
- Completed
Conditions
- Genital Herpes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Famciclovir — DRUGFamciclovir 500 mg tablet
- Valacyclovir — DRUGValacyclovir 500 mg capsule
- Placebo matching famciclovir — DRUGFamciclovir placebo, matching in size, color and forms of famciclovir tablet.
- Placebo matching valacyclovir — DRUGValacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Study Details
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
Key Dates
- Start date
- Mar 31, 2006
- Status verified
- Jun 2011
- Primary completion
- Feb 29, 2008
- Completion
- Feb 29, 2008
Study Design
- Enrollment
- 1,179 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: FamciclovirPatients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
- Active Comparator: ValacyclovirPatients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
Primary Outcome Measure
Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]